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Warning Letter 320-25-114

September 23, 2025

Dear Ms. Person:

The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Persōn & Covey, Inc., FEI #2011222, located at 616 Allen Avenue, Glendale, CA 91021, from January 27 to February 6, 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).

In addition, Xerac AC and Drysol drug products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a). Introducing, or delivering unapproved new drug products for introduction into interstate commerce is a violation under sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C., 331(d) and 355(a). These violations are described in more detail below.

We reviewed your February 19, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. Your responses are inadequate because you failed to provide supportive documentation for evaluation or adequate evidence of corrective actions taken to bring your operations into compliance with CGMP.

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

1. 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).

A. Your quality unit (QU) failed to adequately document and investigate multiple out-of-specification (OOS) results. Specifically, our inspection found that:

• Bulk Intermediate lot (b)(4), Xerac AC, failed the active ingredient content (Aluminum Chloride Hexahydrate) test four times prior to release for further processing, using the (b)(4) Spectrophotometer. You released the material after the (b)(4) sample obtained a passing result, which was the only test result attributed to bulk lot (b)(4). The initial (b)(4) test results were disregarded and not investigated by your QU.
• The inspection documented that “System Administrator” was the only user type attributable in the (b)(4) Software and laboratory personnel shared a common password for the Windows and (b)(4) software systems. Also, audit trails are not independently reviewed after analysis or at an established frequency; and there is no review of the electronic raw data or printed hard copy data.

In your response, you indicate that “There was never a formal procedure for Data Integrity” and you commit to developing one. Your response is inadequate. Your response did not include an assessment or commitment to determine the extent of documentation deficiencies throughout your firm and impact to the safety, effectiveness, and quality of the drug products you continue to manufacture.

Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA’s guidance document Data Integrity and Compliance With Drug CGMP for guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers.

In response to this letter, provide:

• A comprehensive investigation into the extent of the inaccuracies in data records and reporting including results of the data review for drugs distributed in the United States. Include a detailed description of the scope and root causes of your data integrity lapses.
• A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity and analyses of the risks posed by ongoing operations.
• A management strategy for your firm that includes the details of your global corrective action and preventive action plan. The detailed corrective action plan should describe how you intend to ensure the reliability and completeness of all data generated by your firm including microbiological and analytical data, manufacturing records, and all data submitted to FDA.

B. Appropriate procedures are not followed by your QU to ensure adequate oversight.

On November 18, 2021, both your Quality Assurance (QA) and Quality Control (QC) units approved the disposition of Solbar Zinc Sunscreen finished batch (b)(4) for destruction due to a high pH result of the finished drug product. However, this batch was reworked in March 2022 without a pre-approved rework protocol, as required by your procedure. The rework conducted was not contemporaneously documented. The inspection also documented that a batch record for the reworked Solbar Zinc Sunscreen batch was not generated. Instead, QC management issued an internal memo post-processing that lacked the following: lot number of the additional components added, specific equipment used to rework the batch, mixing speed and duration, description and lot number of final container, weight and yield of the reworked batch, additional processing time, sampling details, number of pieces filled, and the assigned expiry date.

After the batch was released, QC management distributed an email identifying the date of release, the container size, and the number of pieces released. The inspection documented that the QA management was not involved in the decision to revert the disposition of batch (b)(4) from destruction to rework.

In your response, you acknowledge the observation and commit to redefining roles, responsibilities, and the authority of your QU. However, your response is inadequate because you do not commit to conduct an in-depth investigation into the redisposition, rework, and release of batch (b)(4) and other batches that may have been released without documented QU approval.

In response to this letter, provide:

• A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively exercise its responsibility. The assessment should also include, but not be limited to:
  o A determination of whether procedures used by your firm are robust and appropriate.
  o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices.
  o A complete and final review of each batch and its related information before the QU disposition decision.
  o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all drug products.
  o Describe how top management supports quality assurance and reliable operations, including but not limited to, timely provision of resources to proactively address emerging manufacturing/quality issues and to assure a continuing state of control.

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).

Three over the counter (OTC) drug products: Solbar Zinc Sunscreen, DHS Zinc Shampoo, and DHS Tar Shampoo failed to meet pre-defined quality attributes at multiple timepoints during long-term room temperature storage conditions. A timely and thorough investigation into the root causes of the OOS events was not performed.

• Multiple high pH failures in Solbar Zinc Sunscreen long-term stability studies were investigated in OOS No. 14. The scope of the investigation included four failed stability intervals for batch (b)(4) (e.g., (b)(4)) and two failures for batch (b)(4) (e.g., (b)(4) and (b)(4)). Although the Phase I investigation did not identify any discrepancies in test performance, it does not specify which of the collective six failed timepoints was the subject of the laboratory observation. Retains for the final timepoints for each batch were retested confirming the initial failure but retains from four unrelated batches were also tested to demonstrate that the “… issue comes from the formulation of the product.” The OOS template question of whether a Phase II investigation was required was not completed and remained unanswered.
• The OOS investigation into DHS Zinc Shampoo batch (b)(4) stability failures identified what appeared to be a trend, concluding “it seems that the pH goes above range … For lot (b)(4) at all temperatures … at all months … are above range.” The Summary of Investigation concludes that “Further investigation into product is needed.” However, the OOS template question of whether a Phase II investigation was required was answered, indicating that “No” Phase II investigation was needed.
• The Phase I OOS investigations into coal tar content failures (DHS Tar Shampoo batches (b)(4), and (b)(4)) failed to identify relevant root cause. Assay suitability was suggested as a potential root cause but was rejected by QC management without further investigation into either the validity of the assay results or a Phase II investigation.

Despite the inconclusive Phase I investigations and documented recognition of trending, OOS investigations were repeatedly closed without completion of a Phase II investigation. The Phase I investigations were approved by the Chief Compliance Officer as mandated by procedure “*Only if Phase II investigation isn’t required.” These drug products are currently on the market and within expiry.

Your response is inadequate. You assert that “The discrepancies have been addressed either by Non-Conformance, OOS, or a Deviation by the QA team.” A possible laboratory error is insufficient to close an investigation at Phase I. Whenever an investigation lacks conclusive evidence of laboratory error, a thorough investigation of potential manufacturing causes must be performed. For more information about handling failing, out-of-specification, out-of-trend, or other unexpected results and documentation of your investigations, see FDA’s guidance document Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/investigating-out-specification-oos-test-results-pharmaceutical-production-level-2-revision.

In response to this letter, provide:

• A retrospective, independent review of all invalidated OOS (including in-process and release / stability testing) results for drug products currently in the U.S. market and within expiry as of the date of this letter and a report summarizing the findings of the analysis, including the following for each OOS:
  o Determine whether the scientific justification and evidence relating to the invalidated OOS result conclusively or inconclusively demonstrates causative laboratory error.
  o For investigations that conclusively establish laboratory root cause, provide rationale and ensure that all other laboratory methods vulnerable to the same or similar root cause are identified for remediation.
  o For all OOS results found by the retrospective review to have an inconclusive or no root cause identified in the laboratory, include a thorough review of production (e.g., batch manufacturing records, adequacy of the manufacturing steps, suitability of equipment/facilities, variability of raw materials, process capability, deviation history, complaint history, batch failure history). Provide a summary of potential manufacturing root causes for each investigation, and any manufacturing operation improvements.
• Also, provide a comprehensive review and remediation plan for your OOS result investigation systems. The corrective action and preventive action should include, but not be limited to, addressing the following:
  o QU oversight of laboratory investigations.
  o Identification of adverse laboratory control trends.
  o Resolution of causes of laboratory variation.
  o Initiation of thorough investigations of potential manufacturing causes whenever a laboratory cause cannot be conclusively identified.
  o Adequately scoping of each investigation and its CAPA.
  o Revised OOS investigation procedures with these and other remediations
• In response to this letter provide an action plan to address any drug product quality or patient safety risks for all batches of OTC drug products in U.S. distribution, including potential customer notifications and recalls or market withdrawals.

3. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).

Changes to the formulations of OTC drug products DHS Tar Shampoo and DHS Zinc Shampoo, including the introduction of different inactive ingredients, were made without demonstrating you have a reproducible commercial manufacturing process, or documented evidence that the reformulated drug products will consistently meet their quality attributes throughout shelf-life. The drug products were reformulated between July 2013 and May 2018 without execution of process validation and demonstration of acceptable stability data to establish expiry. Process validations for both drug products were last executed in 1999. The inspection documented similar changes to the Solbar Zinc Sunscreen formulation during the same timeframe, also without process validation and stability data. Process Validation for Solbar Zinc Sunscreen was last performed in 2002.

Subsequent to drug product reformulation, the OOS failures referenced in (b)(4) above, were detected during long-term room temperature stability studies for all three OTC drug products. Modifications to the manufacturing processing parameters for Solbar Zinc Sunscreen batch (b)(4) (April 2023) and DHS Tar Shampoo batch (b)(4) (November 2023) were handwritten comments changing the sequencing of steps, equipment used, temperatures, durations, quantities, and volumes without justification. In August of 2023, your firm implemented a Product Adjustment Form (QCF-068) to document “routine” in-process manufacturing changes made by Quality Control. OOS Investigation No. 14 noted in November 2024 that a likely factor in Solbar Zinc Sunscreen long-term stability pH failures could be “that the Manufacturing process for Solbar Zinc is constantly changing ...”

Your response is inadequate because your CAPA commits to implementing consultant expert opinions and suggestions that you have been in possession of as early as 2022. You failed to implement meaningful corrective actions, interim measures, or to provide an action plan to address any drug product quality or patient safety risks for all batches of OTC drug products in U.S. distribution, including potential customer notifications and recalls or market withdrawals. Further, you ceased to enroll representative batches of Solbar Zinc Sunscreen or DHS Tar Shampoo in annual stability studies in 2024 and DHS Zinc Shampoo in 2023 and 2024 to continue monitoring drug product quality.

In response to this letter, provide:

• A detailed summary of your validation program for ensuring a state of control throughout the drug product lifecycle, along with associated procedures. Describe your program for process performance qualification (PPQ), and ongoing monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control.
• A timeline for performing appropriate PPQ for each of your marketed drug products.
• Process performance protocol(s), and written procedures for qualification of equipment and facilities.
• A detailed program for designing, validating, maintaining, controlling and monitoring each of your manufacturing processes that includes vigilant monitoring of intra-batch and inter-batch variation to ensure an ongoing state of control. Also, include your program for qualification of your equipment and facility.
• A comprehensive, independent assessment and CAPA plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:
  o 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 batches of each drug 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).
• All procedures that describe these and other elements of your remediated stability program.

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.

Unapproved New Drugs

Xerac AC and Drysol products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body.

Examples of claims, from labeling from your firm’s website and labeling submitted to the electronic Drug Registration and Listing System, that provide evidence of the intended uses (as defined in 21 CFR 201.128) of your drug products include, but may not be limited to, the following:

Xerac AC

• Intended for topical application as an antiperspirant (anhidrotic) for patients suffering from hyperhidrosis, or patients whose jobs or sports activities cause excessive sweating that exacerbates other skin problems.

Drysol

• Intended for severe hyperhidrosis.

Your drug products Xerac AC and Drysol are not generally recognized as safe and effective (GRASE) for their above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). Subject to certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). There are no FDA-approved applications in effect for your drug products. Accordingly, these drug products are unapproved new drugs marketed in violation of sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Cosmetics Manufactured for Distribution in the United States

In addition, some of the products you manufacture may be regulated as cosmetics, as defined in section 201(i) of the FD&C Act [21 U.S.C. 321(i)]. Any cosmetics you manufacture must comply with applicable statutory and regulatory requirements, including the FD&C Act. We note that under section 301(a) of the FD&C Act [21 U.S.C. 331(a)], it is a prohibited act to introduce or deliver for introduction into interstate commerce a cosmetic that is adulterated or misbranded.

We also note that the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) provides new requirements with which facilities that manufacture cosmetic products must comply. You may find the FD&C Act, MoCRA, and FDA’s regulations through links on FDA’s website at www.fda.gov.

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 2011222 and ATTN: Kara S. Quinn.

Sincerely,
/S/

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

/S/

Brad Pace, J.D.
Associate Director
Office of Unapproved Drugs and Labeling Compliance
Signed on behalf of:

Tina Smith
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs & Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research