FDA WARNING_LETTER - Medical Products Laboratories, Inc. - October 16, 2025

Medical Products Laboratories, Inc. received a warning letter from the FDA following an inspection of its Philadelphia facility conducted between September 29 and October 16, 2025. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations and the Federal Food, Drug, and Cosmetic Act. A primary concern was the firm’s failure to prevent microbiological contamination; the company reportedly used unvalidated treatments to reduce bacteria levels and released products that failed contamination tests. Additionally, the FDA found that the company did not adequately validate its manufacturing processes, often relying on incomplete data or studies from different facilities. Quality investigations into product failures—including subpotent test results and customer complaints about product crystallization—were also found to be insufficient. The agency further identified several products, such as Hydro-Q Gel and various Sodium Sulfacetamide and Sulfur formulations, as unapproved new drugs that were being marketed without required FDA authorization. Finally, the company’s stability program lacked the scientific data necessary to support its labeled storage conditions and expiration dates. To address these issues, the FDA requires the company to perform comprehensive risk assessments for all distributed products, remediate its manufacturing and stability protocols, and engage a qualified independent consultant to audit its operations. The firm must provide a detailed written response within 15 working days outlining its corrective actions and plans to ensure future compliance.