The FDA slapped a German contract manufacturer with a Form 483 for serious data integrity violations found in an inspection of its facility in Bavaria.
CPM Contract Pharma, located outside of Munich, didn’t properly assign user permissions for its high-performance liquid chromatography (HPLC) equipment to ensure data was accurate and consistent. Specifically, all authorized users, including analysts who used the equipment for testing, could modify and delete data, project files and methods on the machine, the FDA investigator said.
Hard copy HPLC data for the assay and identity testing of two product batches was reappraised by secondary reviewers, but they failed to compare and verify the data with the electronic data stored on the HPLC equipment.
The agency investigator also flagged the firm’s handling of complaints. Its standard operating procedure for complaint management failed to require the evaluation of previous complaints or to extend investigations to other products that might be connected to the failure.