FDA Warning Letters

Daily Manufacturing Solutions Inc Nicotine Pouch Violations

The FDA Center for Tobacco Products has determined that Daily Manufacturing Solutions Inc. (Rancho Cucamonga, CA) manufactures and distributes new tobacco products—specifically nicotine pouch products including PUCK COOL MINT 6MG—without required premarket authorization. The identified products are adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6). The firm is required to submit a written response within 15 working days describing corrective actions and compliance plans.

Pro Numb Tattoo Numbing Spray LLC - Warning Letter 320-26-63 for CGMP Violations

FDA issued Warning Letter 320-26-63 to Pro Numb Tattoo Numbing Spray, LLC on April 14, 2026, citing significant CGMP violations discovered during a November 5-6, 2025 inspection of its Palm Bay, FL drug manufacturing facility. The firm failed to perform adequate finished product testing before release and distribution, violated component testing requirements, and relied on supplier COAs without establishing reliability. Products including PRO NUMB TATTOO NUMBING SPRAY and TKTX Deep Numbs are adulterated, unapproved new drugs, and misbranded. FDA requires a comprehensive response addressing laboratory practices, raw material testing, supplier qualification, and retrospective testing of distributed batches.

SaNOtize NOWONDER Nasal Cleanser Unapproved New Drug Warning

FDA issued a Warning Letter to SaNOtize (Vancouver, BC) and its US subsidiary NoWonder, Inc. (Sandy, UT) on April 17, 2026, for marketing 'NOWONDER Nasal Cleanser' as an unapproved new drug in violation of Section 505(a) of the FD&C Act. The product, which claims to use nitric oxide to fight viruses and bacteria including influenza and SARS-CoV-2, has no FDA-approved application. FDA requires a written response within 15 working days detailing corrective actions or justification for continued marketing.

Warning Letter: ZYN Cool Blueberry and ZYN Red Fruits Nicotine Pouches Sold Without Marketing Authorization

The FDA Center for Tobacco Products issued a Warning Letter to nicoprof.com (reference RW2602403) on April 17, 2026, for offering two nicotine pouch products for sale in the United States without required premarket authorization. The products — ZYN Cool Blueberry and ZYN Red Fruits (9mg) — are classified as new tobacco products under section 910(a) of the FD&C Act and are adulterated under section 902(6)(A) and misbranded under section 903(a)(6). The firm is required to submit a written response within 15 working days describing corrective actions and plans for ongoing compliance, and faces potential enforcement including civil money penalties, seizure, and/or injunction.

New Life Pharma LLC FDA Warning Letter CGMP Violations

FDA issued Warning Letter 320-26-65 to New Life Pharma LLC at 265 Livingston Street, Northvale, NJ, on April 14, 2026, following an inspection from February 3-13, 2026. The firm was cited for manufacturing and distributing unapproved new drugs (Semaglutide Sterile Multi-Dose Vial and Tirzepatide Sterile Multi-Dose Vial) without FDA-approved applications, for misbranding due to improper firm registration and failure to list drugs with FDA, for CGMP violations including failure to maintain sterility controls for drug products purporting to be sterile, and for delaying, denying, limiting, or refusing to permit an FDA inspection. The products are also adulterated under sections 501(a)(2)(B) and 501(j) of the FD&C Act.

Warning Letter to vapepengood.com for Marketing Unauthorized Nicotine Pouches

The FDA Center for Tobacco Products issued a warning letter to vapepengood.com (Flushing, NY) on April 9, 2026, for marketing unauthorized nicotine pouch products, specifically Icy Blackcurrant XX Strong Nicotine Pouches by Zyn and Zyn Red Fruits Nicotine Pouches, without required premarket authorization under section 910(c)(1)(A)(i) of the FD&C Act. The products are adulterated under section 902(6)(A) and misbranded under section 903(a)(6). The firm must respond within 15 working days describing corrective actions and a compliance plan, and failure to address violations may result in civil money penalties, seizure, and/or injunction.

CGMP Violations, Insanitary Conditions, Data Integrity Failures at Chinese Drug Manufacturer

FDA issued Warning Letter 320-26-56 to Xiamen Kang Zhongyuan Biotechnology Co., Ltd., a Chinese drug manufacturer (FEI 3027976266), citing CGMP violations, insanitary conditions, and data integrity failures discovered during an August 12-15, 2025 inspection. Observed violations included grime and discolored lubricant on manufacturing equipment, standing water in production areas, flies and cockroaches in manufacturing spaces, and apparent mold on air-conditioning vents. The firm's Chief Quality Officer admitted to providing false documents related to finished drug product testing, and the firm submitted altered manufacturing records after the original logbook appeared incomplete. FDA placed all drugs from this firm on Import Alert 66-40 on March 20, 2026, and the firm agreed to recall certain lots of mentholated cough drops following a March 4, 2026 teleconference.

Eaglelionton Int'l Trading Co Inc FSVP Warning Letter Brooklyn NY

FDA issued a Warning Letter to Eaglelionton Int'l Trading Co Inc, a Brooklyn-based food importer, following an FSVP inspection conducted January 29 through February 12, 2026, and a prior inspection from May 1-17, 2023. The firm was found to be non-compliant with section 805 of the FD&C Act and 21 CFR part 1, subpart L, specifically for failing to develop, maintain, and follow an FSVP for any imported foods including coconut milk and canned products from identified foreign suppliers. FDA has not received a response to the Form FDA 483a issued on February 12, 2026. The importer must respond in writing within 15 working days with documentation of corrective actions.

FDA Warns Shopcalismokes.com Over Unauthorized Zyn Nicotine Pouches

The FDA Center for Tobacco Products issued a Warning Letter to shopcalismokes.com (Farmington Hills, MI) on April 10, 2026, for selling two unauthorized Zyn nicotine pouch products—Zyn Pouches Slim Cool Skittle 15mg and Zyn Pouches Slim Fizzy Cola 15mg—in the U.S. market without required premarket authorization under Section 910 of the FD&C Act. FDA determined the products are adulterated under Section 902(6)(A) and misbranded under Section 903(a)(6). The firm has 15 working days from receipt to submit a written response describing corrective actions, including dates of discontinued sales and a compliance plan. Failure to comply may result in civil money penalties, seizure, and/or injunction.

UCSF Radiopharmaceutical Facility CGMP Violations Warning Letter

FDA issued a Warning Letter to UCSF Radiopharmaceutical Facility (FEI 3005947301) following an inspection from July 21-24, 2025, citing significant CGMP violations for drug manufacturing. The agency identified inadequate investigations of multiple failing sterility test results from 2022-2023 involving Bacillus species contamination, and failure to follow written quality assurance procedures for environmental monitoring investigations. The facility must conduct a comprehensive retrospective review of all invalidated sterility tests for the past three years and submit a detailed CAPA plan to CDER.

FDA Warns Par Health Endo USA for Sterile Injectable CGMP Violations

FDA issued Warning Letter 320-26-68 to Par Health USA LLC and Endo USA, Inc. on April 15, 2026, for significant CGMP violations observed during an October 6–20, 2025 inspection of their sterile injectable drug manufacturing facility in Rochester, MI. Investigators documented inadequate aseptic processing line design, excessive manual interventions requiring hundreds of interventions per batch, deficient environmental monitoring, and failed unidirectional airflow studies. The FDA determined that drug products manufactured at the facility are adulterated under Section 501(a)(2)(B) of the FD&C Act.

FDA Warns Mohawksmoke.com for Selling Unauthorized Tobacco Products

FDA's Center for Tobacco Products issued a Warning Letter to mohawksmoke.com on April 3, 2026, for selling two unauthorized nicotine pouch products — Zyn Nicotine Pouches 11mg in Apple Mint and Strawberry Cake varieties — without required premarket authorization. The products are classified as adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6). The letter requires a response within 15 working days detailing corrective actions, and warns that continued violations may result in civil money penalties, seizure, and/or injunction.

Schlechter Farms Inc CGMP Food Violations Salem Oregon

Schlechter Farms Inc CGMP Food Violations Salem Oregon

FDA Warning Letter to Rxgoodusa for Unapproved Opioids and Benzodiazepines Sold Online

FDA issued a Warning Letter to Rxgoodusa on April 1, 2026, citing violations of the Federal Food, Drug, and Cosmetic Act for introducing unapproved opioids (tramadol) and benzodiazepines (diazepam) into interstate commerce via www.rxgoodusa.com. The letter notes that FDA previously issued a Warning Letter on August 1, 2025, for similar violations while operating under www.usaquickmeds.com. FDA requests that Rxgoodusa cease offering any unapproved and misbranded drugs for sale to U.S. consumers.

Purolea Cosmetics Lab CGMP Violations Warning Letter 320-26-58

FDA inspected Purolea Cosmetics Lab (FEI 3011669383), 12782 Currie Ct., Livonia, MI, from October 28–30, 2025, and found significant violations of Current Good Manufacturing Practice (CGMP) regulations. The facility lacked adequate separation from external contaminants, had insects, filth, leaves, and clutter in manufacturing areas, failed to conduct microbiological testing of drug products before release, failed to test components for identity and purity, and failed to validate supplier test analyses. Additionally, products including 'Dermveda Extra Strength Shingles Relief' and 'Dermveda Extra Strength Ultra Genital Herpes Relief' were found to be unapproved new drugs intended to treat serious and/or life-threatening conditions. The firm is required to respond with corrective actions and documentation.

Beauty of Aztlan LLC, Unapproved Drug Violations

The FDA issued a warning letter to Beauty of Aztlan LLC on April 2, 2026, for introducing unapproved and misbranded injectable botulinum toxin products into interstate commerce. Specific products identified include "Botulax 100units" and "Innotox 50units" marketed for conditions including blepharospasm and hyperhidrosis without required FDA approval under Section 505(a) of the FD&C Act. The company also failed to require prescriptions and provided inadequate labeling for these prescription drug products.

Online Rx Medz Warning Letter - Unapproved Opioids, Benzodiazepines, and Stimulants

FDA issued a warning letter to Online Rx Medz (www.onlinerxmedz.com) on April 1, 2026, for introducing unapproved and misbranded opioids, benzodiazepines, and Schedule II stimulants into interstate commerce in violation of the FD&C Act. Specific products cited include oxycodone 80mg marketed as 'Oxycodone', alprazolam 2mg marketed as 'Xanax', and amphetamine combination product 30mg marketed as 'Adderall'. FDA requests immediate cessation of all sales of unapproved and misbranded drugs to U.S. consumers, citing public health risks including addiction, abuse, overdose, and death.

Dry Springs Pharmacy Warning Letter - Unapproved Opioids, Benzodiazepines, and Schedule II Stimulants

FDA's Center for Drug Evaluation and Research (CDER) issued a Warning Letter to Dry Springs Pharmacy on April 1, 2026, for operating the website www.dryspringspharmacy.net and introducing unapproved and misbranded drugs into interstate commerce. The violations cover three categories: opioids (oxycodone marketed as 'OxyNorm'), benzodiazepines (alprazolam marketed as 'Yellow Xanax'), and Schedule II stimulants (amphetamine marketed as 'Adderall'). FDA cites violations of sections 301(a), 301(d), 301(k), 502(f)(1), 503(b)(1), and 505(a) of the FD&C Act and requests the pharmacy immediately cease offering any unapproved and misbranded drugs for sale to U.S. consumers.

Chemco Corporation Warning Letter - CGMP and Drug Violations

FDA issued Warning Letter 320-26-60 to Chemco Corporation on April 7, 2026, following an August 11-22, 2025 inspection of its Miami Lakes, FL drug manufacturing facility (FEI 1042599). The agency cited significant CGMP violations including inadequate equipment cleaning, lack of cleaning validation for shared non-sterile equipment, and failure to conduct component identity testing. Several products including 'PRO Nail FUNGUS KILLER' were cited as unapproved new drugs in violation of Section 505(a) of the FD&C Act, and multiple Eternal Spirit Beauty and SPA REDI products were cited as misbranded under Section 502. The firm has been directed to provide a comprehensive retrospective assessment of cleaning effectiveness and a corrective action plan.

Smart Vending Services LLC Warning for Unauthorised Nicotine Pouch Marketing

FDA's Center for Tobacco Products issued a Warning Letter to Smart Vending Services, LLC (Henderson, NV) for marketing HYPPE Wintergreen 8 mg nicotine pouch products without required premarket authorization under Section 910 of the FD&C Act. The products are adulterated under Section 902(6)(A) and misbranded under Section 903(a)(6). FDA requests a written response within 15 working days describing corrective actions, including dates of discontinued violative sales and a compliance maintenance plan. The firm is notified that failure to address violations may result in civil money penalties, seizure, and/or injunction.

FormPour Warning Letter - Unapproved New Drug Sales via eBay

FDA's Center for Drug Evaluation and Research issued a Warning Letter to FormPour and Shuja Arshad on March 31, 2026, for selling an unapproved new drug, the SMGT-GLT-1 Nano Microneedle Patch, through eBay. The product is marketed for Type 2 Diabetes Treatment, Weight Loss, and Cardiovascular Protection with claimed efficacy rates of 98.6%, 97.5%, and 98.1% respectively. FDA determined the product violates Sections 301(d) and 505(a) of the FD&C Act by being an unapproved new drug introduced into interstate commerce. Recipients must respond within 15 working days with specific corrective steps or written justification.

Pure Indulgence Aesthetics - DSCSA Trading Partner and Product Tracing Violations

FDA issued Warning Letter 723267 to Pure Indulgence Aesthetics on April 1, 2026, citing violations of the Drug Supply Chain Security Act (DSCSA) following an inspection in December 2025. The inspection found the firm dispensed significantly more Botox units than documented in purchase records from AbbVie, indicating product was obtained from unauthorized sources. Additionally, FDA investigators found an unlabeled vial containing botulinum neurotoxin type A in the facility's trash, demonstrating failure to engage in transactions only involving products with required product identifiers. The violations expose the firm to potential enforcement action including injunctions, seizures, and civil penalties.

FDA Warning Letter to Guangzhou Huli Technology Co. Ltd. for Unapproved GLP-1 Drug Sales

FDA issued a Warning Letter to Guangzhou Huli Technology Co. Ltd. (dba Fantasy Face) on March 31, 2026, for offering an unapproved new drug for sale on eBay. The company's 'Googeer GLP-1 Weight Control Oral Solution' was marketed with claims including 'Metabolism Support . . . Weight management Blood Sugar Balance' and 'Ideal Body Shaping helps to shape a slim body,' making it a drug under section 201(g)(1) of the FD&C Act. FDA determined the product is a 'new drug' under section 201(p) because it is not generally recognized as safe and effective (GRASE), and no approved application under section 505 is in effect. The company must respond within fifteen working days with specific corrective steps or face seizure and injunction.

Unapproved New Drugs - Mile High Compounds LLC GLP-1/GIP/Glucagon Peptide Compounds

FDA reviewed the website of Mile High Compounds LLC (https://milehighcompounds.is) from January to March 2026 and found that the firm offers unapproved new drugs — GLP-1 SM (Semaglutide), GLP-2 TRZ (Tirzepatide), GLP-3 RT (Retatrutide), and BAC Water — in violation of sections 301(d) and 505(a) of the FD&C Act. The products are marketed with dosing instructions for weight loss, addiction recovery, and metabolic control, despite labeling stating 'research and educational purposes only.' FDA has determined these are 'new drugs' under section 201(p) of the FD&C Act that require approved applications before sale. The firm has 15 working days to respond with corrective actions.

Warning Letter: Gram Peptides - Unapproved Retatrutide and Tirzepatide Sales

FDA issued a Warning Letter to Gram Peptides (Bernard Gramlich) on March 31, 2026, for marketing and selling unapproved new drugs, specifically Retatrutide (labeled as "GLP-1-R peptide") and Tirzepatide (labeled as "GLP-2 peptide"), in violation of sections 301(d) and 505(a) of the FD&C Act. The agency determined the products are "new drugs" under section 201(p) of the FD&C Act because they are not generally recognized as safe and effective, and no approved applications are in effect for them. FDA has given the firm fifteen working days to respond with specific corrective steps or reasoning why no violations exist.

Prime Sciences Warning Letter - Unapproved New Drugs Sold Online

FDA's Center for Drug Evaluation and Research (CDER) issued a warning letter to Prime Sciences of Scottsdale, AZ, finding that the company sells unapproved new peptide drugs online, including Cagrilintide, Retatrutide (GLP1-R), Semaglutide (GLP1-S), Tirzepatide (GLP1-T), and Mazdutide, as well as BAC water as part of a reconstitution kit. Despite labeling the products "for laboratory research purposes only," FDA determined that marketing claims on the company's website demonstrate they are intended for human use in diagnosing, treating, or preventing disease, making them unapproved new drugs under sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act. Prime Sciences has fifteen working days from March 31, 2026 to respond in writing with specific corrective steps taken or to contest the violations.

Dr. Ehsan Sadri - FDA Warning Letter for Clinical Investigation Violations

The FDA issued a Warning Letter to Dr. Ehsan Sadri following an inspection of his clinical site (March 27–April 16, 2025) as part of FDA's Bioresearch Monitoring Program. FDA found that Dr. Sadri failed to ensure two subjects met protocol-specified eligibility criteria before enrollment—one subject's central CEC density measurement was not completed at screening, and another subject's IOP measurement was outside the protocol-specified range at randomization. FDA deemed Dr. Sadri's corrective and preventive action plan inadequate and has given him 15 business days to respond with more detailed plans to ensure adequate oversight and prevent similar violations.

Pink Pony Peptides Warned for Unapproved Peptide Drugs

The FDA reviewed the website of Lovega LLC dba Pink Pony Peptides (Wellington, FL) in December 2025 and determined that the firm is marketing three products—GLP-2 TZ, GLP-3 RT, and Bacteriostatic Water—as unapproved new drugs in violation of sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act. The agency is particularly concerned because injectable products bypass the body's natural defenses and can cause serious or life-threatening conditions. The firm has been given fifteen working days to respond in writing with specific corrective steps or face regulatory or legal action including seizure and injunction.

Warning Letter - PekCura Labs - Unapproved GLP-1 Drugs Sold Online

The FDA issued a Warning Letter to PekCura Labs (Pensacola, FL) on March 31, 2026, finding that the company sells unapproved new drugs including GLP-1-S, GLP-2-T, GLP-3-R, and Bacteriostatic Water through its website pekcuralabs.com. FDA reviewed the website in January 2026 and determined these products are "new drugs" under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), not generally recognized as safe and effective, with no approved applications under section 505. The introduction or delivery of these products into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). FDA requires a written response within fifteen working days detailing corrective steps or reasoning for non-compliance; failure to adequately address the matter may result in seizure and injunction.

Medline Industries LP - NAMIC Angiographic Control Syringe CAPA Violations

FDA issued Warning Letter CMS # 723866 to Medline Industries, LP (NAMIC Division) for Quality System Regulation violations under 21 CFR Part 820 found during a December 1–12, 2025 inspection of the Glen Falls, NY facility. The inspection revealed that NAMIC Angiographic Control Syringes are adulterated due to failures in corrective and preventive action (CAPA) procedures. Medline received 221 complaints and filed 177 MDRs for syringe-manifold disconnections, including one air embolism patient incident and one clinician biohazard exposure, despite its CAPA actions not being commensurate with the identified risk of air embolism. Post-corrective-action CPM rates (16.90, 16.44, and 26.81 for Q1–Q3 2025) exceeded the 15.98 CPM threshold, and Medline failed to re-route the CAPA when effectiveness checks failed. Medline has submitted an 806 Report for voluntary removal of affected devices.

Global Tobacco LLC FDA warning, nicotine pouches

Global Tobacco LLC FDA warning, nicotine pouches

Henan Lvyuan Pharmaceutical Co. Ltd. - CGMP Violations Warning Letter

FDA's Center for Veterinary Medicine issued a Warning Letter to Henan Lvyuan Pharmaceutical Co. Ltd. (FEI 3013253128) on March 26, 2026, citing significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs) following an inspection from September 22-26, 2025. The inspection identified facility maintenance failures including extensive corrosion on pipe connections and water leaks throughout the facility, and deficient master batch records lacking critical parameters such as time limits and material quantities. The letter also raised concerns about cross-contamination risks between penicillin and other drug operations. The company has 15 working days to respond with corrective actions.

FDA Warns buydeltas.com for Selling Unauthorized ZYN Nicotine Pouches

The FDA Center for Tobacco Products found that buydeltas.com offers for sale two ZYN nicotine pouch products (Cucumber Lime Slim 6.5MG and Red Fruits Slim 9MG) without required premarket authorization, rendering them adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6). The company must submit a written response within 15 working days of receipt describing corrective actions and plans for ongoing compliance, or face civil money penalties, seizure, and/or injunction.

Microbiological Testing & Consulting LLC CGMP Violations Warning Letter

FDA issued Warning Letter 320-26-53 to Microbiological Testing & Consulting LLC, a contract testing laboratory in Alsip, IL, for significant Current Good Manufacturing Practice (CGMP) violations discovered during a September 8-16, 2025 inspection. The agency found the firm failed to establish adequate laboratory controls, lacked proper documentation of microbiological testing procedures, and inadequately qualified testing media, rendering drug products tested adulterated under Section 501(a)(2)(B) of the FD&C Act. FDA is requiring the firm to conduct a comprehensive independent assessment of laboratory practices, a retrospective risk assessment of media qualification gaps over three years, and a complete remediation of documentation systems.

4U Health Warning Letter for Unauthorised HIV DBS Card Self-Collection Kit

FDA issued a Warning Letter to 4U Health (Hilton Head Island, SC) on March 17, 2026, for selling an HIV serological diagnostic dried blood spot (DBS) card self-collection kit without marketing authorisation. CBER determined the kit is a device under section 201(h)(1) of the FD&C Act, adulterated under section 501(f)(1)(B) due to lacking an approved PMA or IDE, and misbranded under section 502(o) for failing to provide 510(k) notification. FDA rejected the firm's argument that it merely facilitates access to professional medical services, stating the collection kit itself is a device regardless of physician involvement. The firm must respond within fifteen working days with specific corrective steps.

Yangzhou H&R Plastic Daily Chemical CGMP Warning Letter 320-26-54

FDA issued Warning Letter 320-26-54 to Yangzhou H&R Plastic Daily Chemical Co., Ltd. on March 18, 2026 following an inspection from October 21-24, 2025 that identified three significant CGMP violations: failure to adequately test finished drug products for active ingredient identity and strength before release, failure to verify component identity and establish reliability of supplier test analyses, and failure to establish adequate written production procedures and validate manufacturing processes. The FDA determined that the firm's drug products are adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act.

FDA Warns Matesbrand.com for Selling Unauthorized Nicotine Pouch Products

FDA's Center for Tobacco Products issued a Warning Letter to matesbrand.com (and copied 7D Holdings LLC, 7 Daze LLC, GoDaddy.com LLC, and Shopify Inc.) for offering two nicotine pouch products for sale in the United States without required premarket authorization under section 910 of the FD&C Act. The cited products — Pouchmates Nicotine Pouches in Peach Smoothie and Strawberry Raspberry flavors — are classified as new tobacco products lacking marketing authorization, rendering them adulterated under section 902(6)(A) and misbranded under section 903(a)(6). FDA requests a written response within 15 working days of receipt describing corrective actions taken.

FDA Warning Letter to Longhorn Vaccines and Diagnostics LLC for Quality System Regulation Violations

FDA's Center for Devices and Radiological Health issued a Warning Letter to Longhorn Vaccines and Diagnostics LLC on February 26, 2026, following an inspection October 20–30, 2025, at the firm's Bethesda, Maryland facility. Investigators determined that PrimeStore® MTM, a molecular transport medium device intended for the inactivation and transport of infectious nasal wash and sputum samples, is adulterated under section 501(h) of the FD&C Act due to Quality System Regulation violations at 21 CFR Part 820. The letter documents five categories of violations spanning complaint handling, CAPA, and design controls, with incidents dating back to 2020 including cyanide release, device leakage, ingestion, and skin exposure complaints. The firm must respond in writing within 15 business days of the letter with specific corrective actions.

FDA Warning Letter to ImmunityBio Inc. Regarding ANKTIVA® False or Misleading Promotional Communications

FDA's Office of Prescription Drug Promotion (OPDP) issued a Warning Letter to ImmunityBio, Inc. finding that promotional communications for ANKTIVA® (nogapendekin alfa inbakicept-pmln) — specifically a direct-to-consumer TV ad and a podcast featuring Dr. Patrick Soon-Shiong — are false or misleading, misbranding the drug in violation of the FD&C Act. The promotional materials misleadingly suggest ANKTIVA can cure and prevent all cancer, and promote the drug for unapproved uses. OPDP noted that ImmunityBio received prior Untitled Letters in September 2025 and January 2026 regarding similar misleading presentations, and continues to promote Anktiva in a similarly problematic manner.

Vedic Lifesciences GLP Warning Letter: Falsified Final Reports, Wrong Study Directors, Misidentified Testing Facilities

FDA issued a Warning Letter to Vedic Lifesciences Pvt. Ltd. (Mumbai, India) following an inspection January 13–15, 2025, under the Bioresearch Monitoring Program, finding that Vedic violated Good Laboratory Practice (GLP) regulations under 21 CFR Part 58 in three nonclinical laboratory studies of an investigational drug. Vedic submitted final reports to the sponsor falsely identifying Vedic as the testing facility, falsely listing Vedic personnel as study directors and quality assurance unit personnel, falsely identifying Vedic as the specimen and data storage location, and allowing non-involved personnel to sign study director attestations — despite Vedic acknowledging it is not a testing facility, has no animal facility, and does not serve as study director for any study. Vedic's written response of February 3, 2025, acknowledged outsourcing studies to other testing facilities and described certain corrective actions already implemented since 2022.

FDA Warning Letter to Citra100mg for Unapproved Opioid Sales

The FDA issued a warning letter to Citra100mg (www.citra100mg.com) on March 4, 2026 for selling unapproved opioids, including tramadol marketed as 'Citra 100mg', 'Clovidol 100mg', 'Jpdol 100mg', 'Ol tram 100mg', 'OL-tram Loose Pills', and 'Trakem 100 mg'. The website violated sections 301(a), 301(d), 301(k), 502(f)(1), 503(b)(1), and 505(a) of the FD&C Act by introducing misbranded and unapproved new drugs into interstate commerce. FDA is requesting that www.citra100mg.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers, noting that such drugs may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.

Warning Letter: Patcos Cosmetics Adulterated OTC Drugs Due to CGMP Violations

FDA issued a Warning Letter (320-26-52) to Patcos Cosmetics Pvt. Ltd. on March 12, 2026, following an unannounced inspection from July 14–18, 2025, at the company's drug manufacturing facility in Daman, India (FEI 3009250196). Investigators found insanitary conditions including harborage areas, broken windows, insanitary production-area sinks, and significant water damage in areas where open processing lines operate and finished drug products are stored, rendering the OTC drug products adulterated under Section 501(a)(2)(A) of the FD&C Act. The letter also cites two CGMP violations: failure to maintain buildings in good state of repair (21 CFR 211.58) and failure to conduct identity testing of drug product components (21 CFR 211.84(d)(1)), making the products additionally adulterated under Section 501(a)(2)(B). FDA found the company's August 2025 response inadequate, noting prior commitments from a 2023 warning letter remain unfulfilled. FDA requires a comprehensive remediation plan, detailed sanitary procedures, a CAPA plan, and documented corrective actions.

FDA Warning Letter to OraLabs Inc. for CGMP Violations at OTC Drug Manufacturing Facility

FDA issued Warning Letter 320-26-50 to OraLabs Inc. (FEI 3001237145) following an inspection from September 22–26, 2025 at the firm's Parker, Colorado OTC drug manufacturing facility. Investigators found that OraLabs released multiple batches of OTC drug products without performing required microbiological release testing, and failed to conduct thorough root-cause investigations for microbiological testing failures. The firm confirmed it only performs microbiological testing at customer request, and invalidated OOS results for Bacillus cereus contamination without adequate scientific rationale. OraLabs must provide a comprehensive independent assessment of its laboratory and manufacturing systems, a detailed risk assessment for distributed products, and complete investigations into all batches with potential objectionable contamination.

Warning Letter to Flowchem Pharma Private Limited Over CGMP Violations

FDA issued Warning Letter 320-26-51 to Flowchem Pharma Private Limited (FEI 3019853324) following an inspection of its drug manufacturing facility in Andhra Pradesh, India from September 8–12, 2025. The agency identified three significant CGMP deviations: inadequate equipment cleaning leading to potential cross-contamination, improper material storage including APIs stored outdoors exposed to environmental elements, and failure to validate testing methods for organic impurities with unintegrated unknown peaks in chromatograms. FDA determined the firm's APIs are adulterated under Section 501(a)(2)(B) of the FD&C Act and requested a comprehensive CAPA plan, retrospective cleaning assessment, and remediation timelines.

FDA Warning Letter to Prilla.com for Unapproved Nicotine Pouch Products

FDA's Center for Tobacco Products issued a Warning Letter to Prilla.com (Las Vegas, NV) for marketing new tobacco products—specifically VITO Watermelon 6mg and VITO Mango Fusion 6mg nicotine pouches—without required premarket authorization under Section 910 of the FD&C Act. FDA determined these products are adulterated under Section 902(6)(A) and misbranded under Section 903(a)(6). The letter requests a written response within 15 working days describing corrective actions, including dates of discontinued sale and compliance plans. Failure to comply may result in civil money penalties, seizure, and/or injunction.

FDA Warning Letter to Trangs Group USA Incorporated for FSVP Violations

FDA issued a Warning Letter to Trangs Group USA Incorporated for failing to develop, maintain, and follow a Foreign Supplier Verification Program (FSVP) as required by section 805 of the FD&C Act and 21 CFR part 1, subpart L. An inspection conducted January 13–26, 2026 at the company's Garden Grove, California facility found that no FSVP existed for any imported foods, including Frozen Bao Mini Mushroom Teriyaki Bun from two foreign suppliers. The company must respond in writing within fifteen (15) working days with documentation of corrective actions or face refusal of admission and detention without physical examination (DWPE) of imported foods.

FDA Warning Letter to Rio Verde Food Service Inc. for Seafood HACCP Violations

FDA issued a Warning Letter to Rio Verde Food Service Inc., a Des Moines, Iowa seafood processing facility, following a July 22–25, 2025 inspection that identified serious violations of the seafood HACCP regulation (21 CFR Part 123). The FDA found that the facility's revised HACCP plan for Live Oysters failed to list critical limits that adequately control pathogen hazards at receiving and storage critical control points, and that the corrective action plan does not ensure affected product does not enter commerce. Under 21 CFR 123.6(g), these failures render the Live Oysters adulterated within the meaning of section 402(a)(4) of the FD&C Act. The firm has 15 working days from receipt to respond with specific corrective steps, documentation, and prevention measures.

FDA Warns thesnuslife.com for Under-Age Nicotine Pouch Sales

FDA's Center for Tobacco Products issued a Warning Letter (Ref: RW2602394) to thesnuslife.com after a person under 21 years of age purchased Zyn Red Berry Fizz (Limited Edition) 11mg nicotine pouch product from the retailer's website, violating FD&C Act section 906(d)(5) and rendering the product misbranded under section 903(a)(7)(B). The retailer is required to submit a written response within 15 working days describing corrective actions taken, dates of discontinuation of violative practices, and a compliance plan. Failure to address violations may result in civil money penalties, seizure, and/or injunction.

Fareva Morton Grove Warning Letter for CGMP Violations

FDA inspected Fareva Morton Grove (FEI 1410794) at 6901 Golf Road, Morton Grove, Illinois, from August 4-12, 2025, and found the facility's drug products are adulterated under section 501(a)(2)(B) of the FD&C Act due to significant CGMP violations. Three specific violations were cited: (1) failure to design water-for-injection equipment to ensure chemical and microbiological quality, with persistent failures including Pseudomonas aeruginosa and Serratia marcescens contamination; (2) failure to conduct adequate microbiological testing for each batch; and (3) failure to maintain complete and accurate laboratory records including microbial testing data. The firm must respond in writing within 15 working days of March 3, 2026.

FDA Warning Letter to Raw Bistro Inc. for CGMP and Preventive Controls Violations

FDA issued a Warning Letter to Raw Bistro Inc. (CMS # 719038) following an inspection of its pet food manufacturing facility in Cannon Falls, Minnesota, from September 16–29, 2025. The inspection found the firm's preventive control for pathogens — a (b)(4) wash — was inadequate, as evidenced by FDA sample 1235454 of Raw Bistro Dog Fare Grass-Fed Beef Entrée, lot 239, best by 08/27/2026, which tested positive for Salmonella Paratyphi. The firm conducted a Class I recall of this product on October 10, 2025. FDA cited three specific violations of 21 CFR Part 507: inadequate preventive control implementation, failure to validate the preventive control, and failure to conduct a complete hazard analysis including nutrient deficiency and toxicity hazards. The firm must respond in writing within 15 working days of the letter.