FDA WARNING_LETTER - SV Labs Prescott Corporation - June 13, 2025

The FDA issued a Warning Letter to SV Labs Corporation following an inspection of its Prescott, Wisconsin, drug manufacturing facility from June 10 to 13, 2025. The letter details significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering the company’s drug products adulterated under federal law.

Key violations include the firm’s failure to thoroughly investigate out-of-specification (OOS) results. For instance, an over-the-counter (OTC) SPF 30 sunscreen lotion lot with "too numerous to count" microbial contamination was released without adequate investigation, a repeat observation from a previous inspection. Additionally, an animal drug product was found contaminated with *Burkholderia cepacia complex* (BCC), but the investigation was insufficient, failing to assess other impacted batches or the water system as a source, despite a history of water system failures.

Furthermore, the facility failed to use appropriately designed equipment, specifically its legacy purified water system. This system contained dead legs, creating stagnant areas that fostered microbial contamination, which was confirmed by recurring water and drug product microbial failures.

The FDA deems the company’s responses inadequate and requires several actions. These include a retrospective, independent review of all drug products currently on the U.S. market within expiry to identify and address any substandard quality. SV Labs must also provide an action plan for BCC testing of retain samples, and a comprehensive remediation plan for their OOS investigation systems. Finally, a detailed remediation plan for the water system"s design, construction, and validation, demonstrating its suitability for pharmaceutical use, is mandated.