FDA Flags Critical Water System Failures at Pharma Facility

During an inspection of Fareva Morton Grove, the U.S. Food and Drug Administration identified serious deficiencies in a process system used for manufacturing over-the-counter drugs—likely the facility’s water system. The agency concluded that the system was neither properly designed nor capable of consistently maintaining required chemical and microbiological quality standards.

Despite extensive performance qualification testing showing most samples failed United States Pharmacopeia specifications, the system was still approved and remained in use. Monitoring data over the following two years continued to show frequent deviations, yet no adequate corrective action was taken.

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

Although the company proposed system upgrades and temporary alternative sourcing, the FDA deemed the response insufficient and has demanded a full technical review, requalification, and risk assessment of affected drug products.

22-03-2026