The FDA cited Marlen Manufacturing & Development for unclear CAPA procedures.
The agency issued a Form 483 to the devicemaker following a March inspection of its Bedford, Ohio, facility. Investigators found the facility’s CAPA procedure was incomplete and did not clearly specify when a CAPA is required, and did not establish what documentation is required for a preventive action. The procedure also failed to address verification/validation, effectiveness activities or actions needed to close a CAPA, the agency said.
The agency further found that the facility’s complaint procedure did not explain how complaints were received, documented or assessed, or how the company documented why an investigation was not required. It also did not adequately review complaints to determine whether an MDR was necessary.