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.
The agency considered the company’s response to the inspection findings to be inadequate because it failed to make suitable improvements to its investigation system.
The firm’s quality control unit discarded original personnel training records, and it failed to reassess that personnel were properly trained to perform their assigned functions.
In addition, forms used to document and set tablet inspection machine parameters were found in an office waste bin.
The firm also failed to report tablet weight-check data. The investigator found the firm had programmed its weight checker not to report certain values that varied from the target weight.