The FDA cited Arcamed for deficiencies in its CAPA procedures and issues with its quality audit and employee training procedures after a February/March inspection of the company’s Indianapolis facility.
The investigators found that seven of 11 product nonconformances were marked “Use As Is,” and the box for “CAPA Investigation” was marked “No” for all seven. None of the noncomforances included a scientific explanation for the final disposition.
The company also failed to follow its written procedures when verifying the effectiveness of its CAPAs, with eight of nine closed CAPA files lacking any objective evidence supporting their effectiveness. In six of nine closed CAPA files, the initiation form was not properly completed in compliance with the procedures.