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Warning Letter 320-26-11

October 30, 2025

Dear Dr. Owen:

The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Owen Biosciences, Inc., FEI 1000132299, at 7053 Revenue Drive, Baton Rouge, from March 25 to 27, 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 April 10, 2025 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.

CGMP Violations

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

1. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications designed to assure drug products conform to appropriate standards of identity, strength, quality, and purity. Your firm also failed to have, for each batch of drug product, an appropriate laboratory determination of satisfactory conformance to final specifications for drug products prior to release (21 CFR 211.160(b) and 211.165(a)).

Your firm manufactures various topical over-the-counter (OTC) drug products, including those containing the active ingredient benzoyl peroxide. There is a known degradation mechanism of benzoyl peroxide, under certain conditions, to form benzene, a known carcinogen. Your firm failed to establish scientifically sound and appropriate finished product specifications and failed to conduct benzene testing on your OTC topical drug products prior to release. For example, you manufactured and released at least (b)(4) lots of the (b)(4) 2.5% benzoyl peroxide acne lotion without testing for benzene. FDA laboratory analysis of one lot of (b)(4) 2.5% benzoyl peroxide acne lotion your firm manufactured and distributed yielded excessive benzene levels of more than 20 parts per million (ppm). You failed to ensure that your drug products do not contain unacceptable benzene impurity levels.

During the inspection, you informed our investigator that a retain sample of the FDA-tested lot as well as other lots manufactured of the (b)(4) 2.5% benzoyl peroxide acne lotion were sent to a contract testing laboratory (CTL) to conduct impurity and assay testing.

In your response, you mention that you will use a CTL to conduct benzene testing on the above-mentioned drug product. However, it is not clear if benzene testing will be performed on all lots prior to release. Your response also states that you are not aware of any FDA guideline on benzene testing, but FDA has alerted drug manufacturers of products at risk for presence of benzene that they should be testing those drug products for benzene. For more information see https://www.fda.gov/drugs/pharmaceutical-quality-resources/fda-alerts-drug-manufacturers-risk-benzene-contamination-certain-drugs.

Your response is inadequate because it does not detail any retrospective risk assessments (e.g., the actions that you will take) should any of the lots sent to your CTL for testing yield unacceptable benzene impurity levels. Further, your response lacks information that your CTL is qualified to test your drug products for benzene.

In response to this letter, provide:

• A list of chemical and microbial specifications, including test methods, used to analyze each lot of your drug product before a lot disposition decision.
• A detailed description of the method you establish to test for benzene in finished products prior to release.
• An action plan and timelines for conducting full chemical and microbiological testing of retain samples to determine the quality of all lots of drug product distributed to the United States that are within expiry as of the date of this letter.
• A summary of all results obtained from testing retain samples from each lot of benzoyl peroxide products that are currently on the U.S. market within expiry. If the testing reveals substandard-quality drug products, take rapid corrective actions, such as notifying customers and product recalls.
• 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.

2. Your firm failed to establish an adequate written testing program designed to assess the stability characteristics of drug products (21 CFR 211.166(a)).

Your stability program was not adequate to ensure that the OTC drug products you manufacture maintain their identity, strength, quality, purity, and safety throughout their shelf lives. For example, full shelf-life studies were not conducted for the entire stated expiry period. Additionally, the studies performed lacked adequate identity, microbiological, and impurities testing.

Your response is inadequate because it fails to include sufficient details on your stability program, including how you will ensure adequate ongoing stability testing with scientific justification. Additionally, it does not include a retrospective risk assessment or information on how you will ensure marketed drug products meet stability specifications throughout shelf life.

In your response to this letter, provide:

• A comprehensive, independent assessment and corrective action and preventive action (CAPA) plan to ensure the adequacy of your stability program. Your remediated program should include but not be limited to:
  o Validated stability-indicating methods.
  o Stability studies for each drug product in its marketed container-closure system before distribution is permitted.
  o An ongoing program in which representative lots of each product are added each year to the program to determine if the shelf-life claim remains valid.
  o Detailed definition of the specific attributes to be tested at each station (timepoint). Given that benzene is a known degradant of benzoyl peroxide and FDA analysis yielded excessive levels of benzene in your drug product, include benzene testing at each stability timepoint.
• All procedures that describe these and other elements of your remediated stability program.

3. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).

Your quality unit (QU) is inadequate. Your QU did not provide adequate oversight for the manufacture of your OTC drug products. For example, your QU failed to ensure:

• Review of production and control records to ensure completeness and accuracy (21 CFR 211.192).
• Adequate written procedures to document and investigate any unexplained discrepancy or failure of a batch or any of its components to meet any specifications (21 CFR 211.22(d); 21 CFR 211.192).
• Appropriate change control procedures were followed related to drug product manufacturing (21 CFR 211.22(d)).
• Performance of periodic (i.e., at least annual) product review (21 CFR 211.180(e)).

In your response, you state that you will address nonconforming products by quarantining the products and taking action to eliminate detected nonconformity. You also state that you will “follow the annual review of products,” identify nonconforming products, and make any necessary adjustments with supporting documentation.

Your response is inadequate. You do not adequately detail how your quality function plans to improve its oversight of manufacturing quality. You also fail to assess the effects that your insufficient QU oversight had on product quality.

Your QU is responsible for fully exercising its authority and responsibilities. FDA is concerned that your QU may not be conducting appropriate oversight regarding CGMP operations.

Your firm’s quality systems are inadequate. See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations at https://www.fda.gov/media/71023/download for help with implementing quality systems and risk-management approaches to meet the requirements of CGMP regulations in 21 CFR 210 and 211.

Failed Commitment to Recall Contaminated Drug Lot

FDA sampled and tested one lot of Benzoyl Peroxide Acne Lotion that is used as part of the (b)(4) Acne System Kit. On March 4, 2025, FDA held a teleconference with the drug product distributor, (b)(4), to recommend removal of this product lot from the U.S. market because it contained excessive benzene impurity levels of more than 20 ppm. During that call and again on March 5, 2025, (b)(4) communicated that it would voluntarily recall the product containing the (b)(4) Benzoyl Peroxide Acne Lotion that FDA tested. However, neither Owen Biosciences, Inc. nor (b)(4) recalled the product before it expired.

CGMP Consultant Recommended

Based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements.

Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.

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 adequately address this matter may lead to regulatory or legal action without further notice including, without limitation, seizure and injunction. Other Federal agencies may take your compliance history into account when considering the award of contracts.

Failure to address violations may be cause for FDA to withhold issuance of Export Certificates. Any violations of CGMP requirements may also be cause for FDA to withhold approval of new applications or supplements listing your firm as a drug manufacturer. 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 1000132299 and ATTN: Daniel W. Brisker.

Sincerely,
/S/

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