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.
The agency also found that the company did not use a supplier on its approved supplier list on several occasions, and it did not list a disqualified supplier on the appropriate section of its supplier list as required by company procedures.
The company’s management confirmed it had no internal audit schedule for 2016 and 2017, as required by its internal quality audit procedure, and the only evidence that audits were conducted in 2016 indicated they were partial audits.
In addition, investigators found training records were incomplete for one of three employees reviewed, and did not include evidence of training in risk management and validation, calibration and quality control.