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

Delivery Method: Via Electronic Mail - Return Receipt Requested Reference #: 320-26-50 Product: Drugs
Over-the-Counter Drugs Recipient: Recipient Name Mr. Gary Schlatter Recipient Title CEO OraLabs, Inc. 18685 East Plaza Drive
Parker, CO 80134-9061
United States

gschlatter@oralabs.com Issuing Office: Center for Drug Evaluation and Research (CDER) United States

Warning Letter 320-26-50

March 11, 2026

Dear Mr. Schlatter:

The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, OraLabs Inc., FEI 3001237145, at 18685 East Plaza Drive, Parker, from September 22 to 26, 2025.

This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).

Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).

We reviewed your October 17, 2025, response to our Form FDA 483 in detail.

During our inspection, our investigators observed specific violations including, but not limited to, the following.

1. Your firm failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(b)).

Your firm operates as both a contract and own label manufacturer of over-the-counter (OTC) drug products, including (b)(4) marketed to (b)(4). Your firm released multiple batches of OTC drug products without performing appropriate microbiological release testing. For example, on February 4, 2025, you manufactured over (b)(4) units of (b)(4) (Lot (b)(4)) without performing microbiological testing for release. Your quality unit (QU) approved and released this lot on (b)(4), and distributed it to your customer on (b)(4).

In your response you confirmed that you perform microbiological testing only at your customer’s request. You also provided a justification memo which concluded “no testing required” for total aerobic microbial count, total combined yeasts/molds, and specified microorganisms based on your products being (b)(4). Your response is inadequate. FDA has encountered recalls for microbial contamination in (b)(4) drug products. Your justification memo reveals microbial growth in your drug products. While microbial proliferation risk may be lower, microorganisms can persist in your drug products. Eliminating microbial testing of your drug products is unacceptable. CGMP regulations require written procedures be established to prevent introduction of objectionable microbiological contamination in the manufacture of drug products not required to be sterile.

In response to this letter, provide:

• A comprehensive independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.
• A list of chemical and microbial specifications (i.e., total counts, identification of bioburden to detect objectionable microbes), including test methods, used to analyze each lot of your drug products before a lot disposition decision. o An action plan and timelines for conducting full chemical and microbiological testing of retain samples to determine the quality of all batches of drug product distributed within the United States that are within expiry as of the date of this letter. o A summary of results from testing retain samples of all drug product batches within expiry. You should test all appropriate quality attributes including, but not limited to, identity and strength of active ingredients and microbiological quality (total counts and identification of bioburden to detect any objectionable microbes) of each batch. If testing yields an out-of-specification (OOS) result, indicate the corrective actions you will take, including notifying customers and initiating recalls. 2. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

Your investigations into microbiological testing failures when your customers requested such testing frequently lacked thorough root cause analysis and appropriate corrective actions and preventive actions (CAPAs). For example, you investigated total aerobic counts exceeding specification limits for (b)(4) drug product and identified the microorganism as Bacillus cereus. However, you invalidated this excursion because the specific pathogens listed on the certificate of analysis were not detected. You concluded that the “most likely source of contamination would be from environmental contamination during the manufacturing process.” You lacked adequate scientific rationale to invalidate this excursion.

Additionally, multiple investigations resulted in inconclusive root causes or were invalidated with inconsistent approaches that often lacked thorough manufacturing investigations, environmental sampling, and other potential sources of contamination. Your investigations inappropriately minimized the risk of these microbial excursions by stating that products had lower (b)(4) content and “product does not support growth.” Your conclusions contradict the microbial excursions detected in your test results, and your QU released the associated lots for distribution.

In your response, you commit to evaluating procedures and including additional documentation for OOS results, as well as training employees. Your response does not adequately demonstrate that your firm has remediated its investigational capabilities to ensure comprehensive, well-documented, and scientifically rigorous investigations to effectively identify root causes and result in appropriate CAPAs.

In response to this letter, provide:

• A comprehensive, independent assessment of the design and control of your firm’s manufacturing operations with a detailed and thorough review of all microbiological hazards.
• A detailed risk assessment addressing the hazards posed by distributing drug products with potentially objectionable contamination. Specify actions you will take in response to the risk assessment, such as customer notifications and product recalls.
• Complete investigations into all batches with potential objectionable microbial contamination or a microbial excursion (whether or not later invalidated or inconclusive). The investigations should detail your findings regarding the root causes of the contamination. Responsibilities as a Contractor

Drugs must be manufactured in conformance with CGMP. FDA is aware that many drug manufacturers use independent contractors such as production facilities, testing laboratories, packagers, and labelers. FDA regards contractors as extensions of the manufacturer.

You are responsible for the quality of drugs you produce as a contract facility regardless of agreements in place with product owners. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act for safety, identity, strength, quality, and purity. See FDA’s guidance document Contract Manufacturing Arrangements for Drugs: Quality Agreements at https://www.fda.gov/media/86193/download.

Conclusion

The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.

Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.

Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.

This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.

Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3001237145 and ATTN: Bryce Hammer.

Sincerely,
/S/

Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research

• ## Content current as of:

03/17/2026

• Regulated Product(s)

  • Drugs
  • Over-the-Counter Drugs