Bayer Facility Warned for GMP Noncompliance
The FDA issued a warning letter to Bayer arising from an inspection at a Bayer Pharma facility in North Rhine-Westphalia, Germany.
In an inspection early last year, the FDA’s investigator observed inadequate cleaning practices for non-dedicated equipment, as well as residue on exterior surfaces that were likely from drug products processed in the same room.
White residues were observed in three different rooms around areas identified as “clean,” risking cross-contamination of manufacturing equipment, the agency said.
The investigator also found the facility did not adequately investigate product quality complaints. The firm failed to address a defect reported by a supplier, and after investigating two reports of leakage, the company did not determine the root cause for a container-closure defect.