FDA WARNING_LETTER - Fareva Morton Grove - August 12, 2025

The FDA issued a Warning Letter to Fareva Morton Grove following an inspection from August 4 to 12, 2025, at their Illinois drug manufacturing facility. The agency found significant violations of Current Good Manufacturing Practice (CGMP) regulations, leading to drug products being deemed adulterated under the Federal Food, Drug, and Cosmetic Act. Key issues included the firm"s purified water system, which was inadequately designed and controlled, consistently failing to meet chemical and microbiological specifications. The system harbored bacteria like Pseudomonas aeruginosa and Serratia marcescens, compromising the quality of water used in drug production. Furthermore, the company failed to conduct appropriate microbiological testing on drug product batches, specifically neglecting the identification of gram-negative bacteria as required by their own procedures, despite increasing microbial counts. A critical problem identified was the failure to maintain complete and accurate laboratory records, including unrecorded negative results, discarded positive plates, and missing data, indicating severe data integrity lapses. The FDA requires Fareva Morton Grove to provide a comprehensive remediation plan for its water system, including a thorough validation and monitoring program. They must also conduct a detailed risk assessment for all distributed drug products, perform retrospective testing of retain samples, and implement a robust plan to ensure the Quality Unit"s effectiveness. A complete independent assessment of laboratory practices and documentation systems, along with a global CAPA plan addressing data integrity, is mandated. The FDA strongly recommends retaining a qualified consultant for remediation.