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Warning Letter 320-26-26

December 9, 2025

Dear Mr. Orriss:

The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, SV Labs Prescott Corporation, FEI 2130687, at 1115 Dexter Street North, Prescott, Wisconsin, from June 10 to 13, 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 July 7, 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 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 firm did not adequately investigate out-of-specification (OOS) results associated with your over-the-counter (OTC) human and animal drug products contract manufactured by your facility.

For example, an OTC SPF 30 sunscreen lotion human drug product lot failed your total aerobic microbial count specification with a “too numerous to count” (TNTC) result. Your firm released the lot to your customer without investigating the cause of the microbial failure. During a previous FDA inspection, your firm was also cited for releasing drug product lots with failing microbial results without conducting proper investigations.

On September 17, 2025, FDA held a teleconference with you to discuss SPF 30 sunscreen lotion human drug product, lot (b)(4). During that call, you agreed to voluntarily recall this lot.

Your firm identified Burkholderia cepacia complex (BCC) in an OTC topical fungicide animal drug product lot with production line swab samples confirming growth of gram-negative rods consistent with BCC. While your firm rejected the affected lot and increased cleaning and sanitization of the production line, your investigation was inadequate. You failed to extend the investigation to other potentially impacted batches manufactured on the contaminated equipment and did not adequately evaluate the water system as a potential source of contamination, despite documented water system failures. Since 2023, your firm has recorded numerous water system failures, including uninvestigated microbial tests with TNTC results.

In your response, you acknowledge past inconsistent compliance with your OOS investigation procedures, which you state has been corrected. We note your additional commitments to conduct a retrospective review of manufacturing records to identify other lots with OOS results that you released to the market. You also committed to implementing process improvement corrective action and preventive actions (CAPAs), updating standard operating procedures (SOPs), and training personnel.

Your response is inadequate because it lacks a thorough market suitability analysis for the released sunscreen lot with failing results. Your analysis should include an assessment of risk to consumers and justification for leaving a potentially contaminated product on the market. Additionally, your 12-month retrospective review timeframe is insufficient and should be expanded to cover all products within expiry dates to identify products still in use by consumers. Your response also fails to adequately assess the significance of BCC contamination across your entire product portfolio, particularly given your water system’s documented history of failing microbial test results.

In response to this letter, provide:

• A retrospective, independent review of all manufactured 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. If such review reveals substandard quality drug products (including lots with OOS results), take rapid corrective actions, such as notifying customers and market action.
• An action plan and timelines for conducting BCC testing of retain samples to determine the quality of all batches of drug products distributed to the United States that are within expiry as of the date of this letter, and a summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and market action.
• A comprehensive review and remediation plan for your OOS result investigation systems. The CAPA should include, but not be limited to, the following:
  o Quality unit 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

2. Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63).

Your firm has not demonstrated that the (b)(4) water that you use as a component is suitable for aqueous-based drug product manufacturing and, at a minimum, meets the United States Pharmacopeia (USP) (b)(4) Water monograph and appropriate microbial limits.

Your legacy (b)(4) water system included two dead legs that create stagnant areas, fostering biofilm development and microbial contamination. This risk is compounded by your documented history of water system and drug product microbial failures which include TNTC results. These fundamental design deficiencies posed contamination risks to all products manufactured using this water.

In your response, you acknowledge that your facility experienced significant water system deficiencies that required comprehensive remediation efforts and installation of a new (b)(4) water system capable of producing water suitable for its intended purpose. Your response also includes corrective actions such as decommissioning your legacy system, implementing controlled data collection forms, retraining staff on good documentation practices, updating water monitoring SOPs and conducting an impact analysis of products manufactured prior to the improvements.

Your response is inadequate. Although you commit to decommissioning the legacy system after validating your new water system, your response does not provide supportive documentation to demonstrate that the new water system is validated for its intended use. Additionally, your response lacks adequate details to ensure that your sampling, testing, and monitoring procedures can meet USP (b)(4) Water monograph requirements.

Pharmaceutical water must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate chemical and microbiological attributes.

In response to this letter, provide:

• A comprehensive remediation plan for the design, control, and maintenance of the water system.
  o Validation report for the water system obtained after an appropriately designed system has been installed. Include the system validation protocol, the complete test results, and the final validation report.
• Your total microbial count limits to monitor whether this system is producing water suitable for the intended uses for each of your products.
• A detailed risk assessment addressing the potential effects of the observed water system failures on the quality of all drug product lots currently in U.S. distribution or within expiry. Specify actions that you will take in response to the risk assessment, such as customer notifications and product recalls.
• A procedure for your water system monitoring that specifies routine microbial testing of water 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) water system. Ensure that the total count limits for your (b)(4) water are appropriately stringent in view of the intended use of each of the products produced by your firm.
• A procedure governing your program for ongoing control, maintenance, and monitoring that ensures the remediated system consistently produces water that meets (b)(4) Water USP monograph specifications and appropriate microbial limits.

3. Your firm failed to establish 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 lacks process validation studies to demonstrate reproducibility and control of manufacturing processes to ensure uniform product quality. Your firm's extensive history of assay failures in both animal and human over-the-counter drug products, requiring reprocessing indicates poor manufacturing control. Additionally, your firm’s cleaning procedures for shared equipment, particularly filling equipment used to manufacture multiple products including drug products, have not been validated.

In your response, you commit to validating your OTC drug product manufacturing processes and equipment cleaning procedures in established timeframes. You also state that you will conduct a retrospective product review.

Your response is inadequate. It lacks sufficient details regarding your planned retrospective review of drug products manufactured using unvalidated processes with no clarification on whether the analysis will encompass lots that failed assay testing or underwent reprocessing. Furthermore, while your firm recognizes the use of multiple potent and chemically diverse substances at the facility, your response fails to identify these substances and does not commit to performing a risk assessment to determine if these compounds are processed on shared equipment.

Process validation evaluates the soundness of design and 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 include intensive monitoring and testing throughout each significant process stage to characterize intra-batch variation and evaluate batches to 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 you maintain a stable manufacturing operation throughout the product lifecycle.

See FDA’s guidance document Process Validation: General Principles and Practices for general principles and approaches that FDA considers appropriate elements of process validation at https://www.fda.gov/media/71021/download.

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 intra-batch and inter-batch variation to ensure a continuing state of control.
• A timeline for performing process performance qualification for each of your marketed drug products. Also provide a risk assessment and any follow up actions to be taken for the distributed drug products produced without performing any process validation studies.
• 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.
• 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 with higher toxicities
  o Drugs with higher drug potencies
  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.

4. 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) did not provide adequate oversight for the manufacture of your drug products. For example, your QU failed to ensure the following:

• Appropriate controls were exercised over computer systems to ensure only authorized personnel make changes to master production and control records or other records (21 CFR 211.68(b)).
• Adequate laboratory controls were established with proper specifications, standards, sampling plans, and test procedures to ensure materials and drug products meet required identity, strength, quality, and purity standards (21 CFR 211.160(b)).
• An adequate written stability testing program for drug products (21 CFR 211.166(a)).
• Laboratory records included complete data from all required tests for compliance with specifications and standards (21 CFR 211.194(a)).

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

In your response, you provide corrective actions for each deficiency with specific timeframes.

Your response is inadequate because it fails to address the systemic quality deficiencies identified during the inspection. The observed lapses, including but not limited to laboratory controls, documentation practices, and data integrity controls, many of which were also identified during previous inspections, indicate fundamental weaknesses in the QU’s oversight function. The proposed corrective actions do not adequately demonstrate how you will strengthen quality oversight to ensure ongoing compliance with CGMP requirements.

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:
  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 products
• A complete assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed CAPA plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous records throughout your operation.

CGMP Consultant Recommended

Based upon the nature of the violations we identified at your firm and because you failed to correct repeat violations, you should engage a consultant, qualified as set forth in 21 CFR 211.34, to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your CAPAs before you pursue resolution of your firm’s compliance status with FDA.

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 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 2130687 and ATTN: Rory Geyer.

Sincerely,
/S/

Jill P. Furman, J.D.
Director
Office of Compliance
Center for Drug Evaluation and Research 

/S/

Dillard H Woody Jr.
Acting Drug Compliance Director
Office of Surveillance and Compliance
Center for Veterinary Medicine