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Warning Letter 320-26-25

December 9, 2025

Dear Mr. Sklar,

The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Sklar Personal Care Inc. (DBA BOV Solutions), FEI 3007953761, located at 1105 E Garner Bagnal Boulevard, Statesville, North Carolina 28677, from May 19 to May 23, 2025 and June 9, 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 June 16, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.

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

1. Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21CFR 211.84(d)(1).

Your firm failed to adequately test your incoming components for identity before using the components to manufacture your OTC drug products. Specifically, your firm did not perform identity testing for the following raw materials: (b)(4), which are used in the production of (b)(4) batch (b)(4).

We also note that you use raw material (b)(4) to manufacture your OTC drug products. However, testing for the presence of methanol is not performed for incoming (b)(4).

The use of (b)(4) contaminated with methanol has resulted in various lethal poisoning incidents in (b)(4).

Without adequate testing, you do not have scientific evidence that your raw materials conform to appropriate specifications before their use in the manufacture of your drug products. As a manufacturer, you have a responsibility to sample, test, and examine drug components before their use in production to ensure adequate quality.

In your response, you commit to updating testing specifications and prioritizing the identity testing of raw materials on order for the remaining production planned in 2025. You also commit to ensuring that every (b)(4) container delivered will be tested for methanol by July 31, 2025.

Your response is inadequate. You did not provide a risk assessment addressing the use of untested raw material in your finished OTC products. In your response, you did not commit to testing the remaining raw materials or the retain samples of the OTC drug products already distributed.

In response to this letter, provide:

• A comprehensive review of your material system to determine whether all suppliers of components, containers, and closures are each qualified, and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures.
• A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s COA instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier’s results through initial validation as well as periodic revalidation. In addition, include a commitment to conduct at least one specific identity test for each incoming component lot as required.
• Identity test results of raw materials currently in inventory. In the instance of no remaining raw material is available or within expiry, provide the test results for methanol that may be present in your finished OTC drug products.

2. Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).

You lacked the cleaning validation studies required by your written procedures for OTC drug products. You failed to demonstrate your cleaning practices are adequate to remove potential contaminants and to prevent product carry over in shared equipment (for example, fillers and small utensils used for formulation) used to manufacture your OTC drug products.

Inadequate removal of residues from manufacturing equipment during cleaning can lead to the contamination of drug products subsequently manufactured on nondedicated equipment.

In your response, you commit to conducting cleaning verifications for the removal of residues left by cleaning chemicals and organic materials. Specifically, you commit to completing a cleaning validation by the end of Q4 of 2025.

Your response is inadequate. You fail to provide specific details, such as predetermined acceptance criteria, cleaning frequency, and procedures and acceptable holding time limit for dirty equipment, supported by cleaning validation. Furthermore, you fail to assess the impact of your inadequate cleaning processes on product that is currently on the market and within expiry. Of note, cleaning deficiencies were discussed with your firm in a previous FDA inspection.

In response to this letter, provide:

• An interim protocol for your cleaning verification with acceptance criteria, sampling methods, locations, and other considerations relevant to your equipment cleaning program.
• A corrective action and preventive action (CAPA) plan, based on the retrospective assessment of your cleaning program, that includes appropriate remediations to your cleaning processes and practices and timelines for completion. Provide a detailed summary of vulnerabilities in your process for lifecycle management of equipment cleaning. Describe improvements to your cleaning program, including enhancements to cleaning effectiveness; improved ongoing verification of proper cleaning execution for all products and equipment; and all other needed remediations.
• Appropriate improvements to your cleaning validation program, with special emphasis on incorporating conditions identified as worst case in your drug manufacturing operation. This should include but not be limited to, identification and evaluation of all worst-case:
  o Drugs of lower solubility in their cleaning solvents
  o Drugs with characteristics that make them difficult to clean
  o Swabbing locations for areas that are most difficult to clean
  o Maximum hold times before cleaning
• In addition, describe the steps that must be taken in your change management system before introduction of new manufacturing equipment or a new product.
• A summary of updated SOPs that ensure an appropriate program is in place for verification and validation of cleaning procedures for products, processes, and equipment.
• A detailed risk assessment addressing the hazards posed by distributing drug products (such as (b)(4)) manufactured using shared equipment that may have been improperly cleaned. Specify actions you will take in response to the risk assessment, such as customer notifications and product recalls.

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)).

Your firm failed to conduct process validations for all your over-the-counter (OTC) drug products, including but not limited to your (b)(4) products. Our investigators also found three instances of bulk lot (b)(4) for your (b)(4) due to out of specification results

Process validation evaluates the soundness of design and the state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately and assure the quality of raw material inputs, in-process materials, and finished drugs. Process qualification studies determine whether an initial state of control has been established. Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and product quality is necessary to ensure that you maintain a stable manufacturing operation throughout the product lifecycle. See FDA’s guidance for industry Process Validation: General Principles and Practices at https://www.fda.gov/media/71021/download for general principles and approaches that the FDA considers appropriate elements of process validation.

In your response, you state that you will perform an evaluation and create a gap analysis to prioritize the completion of products and formulations requiring validation. You commit to have a validation protocol completed before the next scheduled run on nonvalidated products, so the validations can be conducted concurrently.

Your response is inadequate. You did not provide an impact assessment on the drugs you distributed without completing validation studies to ensure acceptable quality of your drug products.

Additionally, based on inspection findings, your (b)(4) system was not in a state of control because of inadequate testing and monitoring and inadequate sanitization. You use (b)(4) as a component in your drug products and for equipment cleaning. (b)(4) for pharmaceutical purposes must be suitable for its intended use and must be routinely tested to ensure ongoing conformance with appropriate chemical and microbiological attributes. The lack of adequate monitoring provides no assurance the system performs as intended.

In your response, you commit to adding additional testing points and reinstating the (b)(4) testing frequency. You also commit to monitoring and documenting the water system maintenance performed by the contractor.

Your response is inadequate. You fail to address the effects on the product resulting from the use of (b)(4) that is not adequately tested and monitored for its intended use.

In response to this letter, provide:

• A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle, along with associated procedures. Describe your program for process performance qualification and ongoing monitoring of both intrabatch and interbatch variation to ensure a continuing state of control.
• A timeline for performing process performance qualification for each of your marketed drug products.
• Process performance protocol(s) and written procedures for qualification of equipment and facilities.
• A procedure for your (b)(4) system monitoring that specifies routine microbial testing of (b)(4) to ensure its acceptability for use in each batch of drug products produced by your firm.
• The current action/alert limits for total counts and objectionable organisms used for your (b)(4) system.
• A procedure governing your program for ongoing control, maintenance, and monitoring that ensures the remediated system consistently produces (b)(4) that meets (b)(4) monograph specifications and appropriate microbial limits.

4. Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such written procedures (21 CFR 211.22 (d)).

You lacked adequate quality unit (QU) oversight for the manufacture of your OTC drug products. For example:

• You have not performed an annual product review (APR) of your OTC drug products manufactured since 2022.
• You failed to follow your procedure for raw material sampling, in that multiple different materials were held in the sampling area, which poses the risk of potential contamination and mix-ups.

An adequate QU overseeing all manufacturing operations is necessary to consistently ensure drug quality. 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 in implementing quality systems and risk management approaches to meet the requirements of CGMP regulations (21 CFR parts 210 and 211).

In your response, you commit to ensuring that procedures are followed and that programs are up to date and complete going forward.

Your response is inadequate. Although you commit to addressing the observations we identified, your response lacks sufficient details about the systemic remediations needed for your QU and your quality system.

In response to this letter, provide:

A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include but not be limited to:

• A determination of whether procedures used by your firm are robust and appropriate.
• Provisions for QU oversight throughout your operations, to evaluate adherence to appropriate practices.
• A complete and final review of each batch and its related information before the QU disposition decision.
• Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.

CGMP Consultant Recommended

Based upon the nature of the violations we identified at your firm, and because you failed to correct repeat violations, we strongly recommend that your firm 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.

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 address this matter promptly and adequately 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 3007953761 and ATTN: Joan Johnson.

Sincerely,
/S/

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