FDA Flags Major Compliance Gaps at Fareva Morton Grove Facility

The U.S. Food and Drug Administration has identified significant compliance failures at a U.S. site operated by Fareva Morton Grove, citing critical issues in a process system used for over-the-counter drug manufacturing—likely the facility’s water system.

According to the agency, the system failed to consistently meet chemical and microbiological standards outlined by United States Pharmacopeia. During performance qualification, most samples did not meet specifications, yet the system was approved and remained in use despite persistent deviations over two years.

The FDA highlighted major design flaws, including dead legs and stagnant zones that can promote biofilm formation. Microbial testing repeatedly detected organisms such as Pseudomonas aeruginosa and Serratia marcescens.

While the company plans system upgrades and temporary reliance on external sources, the FDA has called for a comprehensive redesign, requalification, and risk assessment of potentially affected drug batches.

08-04-2026