FDA Warning Letters

Pure Indulgence Aesthetics - DSCSA Trading Partner and Product Tracing Violations

FDA issued a Warning Letter to Pure Indulgence Aesthetics, a medical spa in Southlake, TX, identifying DSCSA violations under Section 582(d) of the FD&C Act. Investigators found the firm dispensed significantly more Botox units than documented in purchase records from AbbVie, indicating potential sourcing from unauthorized trading partners. The firm must respond with corrective actions within the specified timeframe.

FormPour Warning Letter - Unapproved New Drug Sales via eBay

FDA issued a warning letter to FormPour (Shuja Arshad) for selling an unapproved new drug product, the 'SMGT-GLT-1 Nano Microneedle Patch,' on eBay. The product makes unapproved claims for treating Type 2 diabetes, weight loss, and cardiovascular protection, violating sections 301(d) and 505(a) of the FD&C Act. The recipient has 15 working days to respond with corrective actions or face seizure and injunction.

Pink Pony Peptides - Unapproved New Drugs Warning

FDA issued a Warning Letter to Lovega LLC dba Pink Pony Peptides for marketing and selling unapproved new drugs, including peptide products GLP-2 TZ, GLP-3 RT, and Bacteriostatic Water. The products were found to be marketed with therapeutic claims despite labeling stating 'not for human consumption.' FDA determined the products meet the definition of new drugs under the FD&C Act and require approved applications before sale.

Unapproved New Drugs - GLP-1/GIP/Glucagon Peptide Compounds

FDA issued a Warning Letter to Mile High Compounds LLC for marketing unapproved new drugs, including GLP-1 SM, GLP-2 TRZ, and GLP-3 RT peptide compounds, via their website. The agency determined these products are drugs under section 201(g)(1) of the FD&C Act because labeling and marketing materials make therapeutic claims for weight loss, addiction recovery, and metabolic control despite labeling disclaimers. The FDA cites violations of sections 301(d) and 505(a) of the FD&C Act for introducing unapproved drugs into interstate commerce.

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

The FDA's Center for Drug Evaluation and Research issued a Warning Letter to Guangzhou Huli Technology Co., Ltd. (dba Fantasy Face) on March 31, 2026, for selling unapproved new drugs through its eBay store. The company's 'Googeer GLP-1 Weight Control Oral Solution' is marketed as a weight loss and metabolism support product but lacks FDA approval under Section 505 of the FD&C Act. The FDA has demanded the company respond within 15 working days with corrective actions or face potential seizure and injunction.

Medline Industries LP - Quality System Regulation Violations Warning Letter

FDA issued a Warning Letter to Medline Industries, LP (NAMIC Division) citing Quality System Regulation violations under 21 CFR Part 820. The inspection conducted December 1-12, 2025 identified CAPA procedure failures involving NAMIC Angiographic Control Syringes that generated 221 complaints and 177 MDRs, including documented cases of air embolism patient harm and biohazard exposure to clinicians.

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

FDA issued a Warning Letter to PekCura Labs (Pensacola, FL) on March 31, 2026, for selling unapproved new drugs including GLP-1-S, GLP-2-T, GLP-3-R, and Bacteriostatic Water through their website. The products are unapproved drugs under Section 505(a) of the FD&C Act, despite labeling claims that they are for 'research use only' and 'not for human consumption.' The FDA determined these injectable products pose serious public health risks because they bypass natural body defenses when delivered directly into the bloodstream.

Prime Sciences Warning Letter - Unapproved New Drugs Sold Online

The FDA issued a warning letter to Prime Sciences (Scottsdale, AZ) for selling unapproved new drugs online through their website. The products at issue include Cagrilintide, GLP1-R (Retatrutide), GLP1-S (Semaglutide), GLP1-T (Tirzepatide), Mazdutide, and BAC water. These products are being marketed for human use in weight loss and diabetes management despite labeling that claims 'research purposes only' and 'not for human consumption.' The FDA determined these are unapproved new drugs under Section 505(a) of the FD&C Act.

Ehsan Sadri MD - FDA Warning Letter - Clinical Investigation Violations

FDA issued a Warning Letter to Dr. Ehsan Sadri, a clinical investigator, citing violations of 21 CFR 312.60 observed during an inspection of his clinical site in March-April 2025. The inspection, part of FDA's Bioresearch Monitoring Program, found that Dr. Sadri enrolled subjects who did not meet protocol-specified eligibility criteria, including missing required screening assessments and enrolling a subject with intraocular pressure outside the required range.

Global Tobacco LLC FDA warning, nicotine pouches

Global Tobacco LLC FDA warning, nicotine pouches