An FMI Medisch manufacturing facility in Schiedam, The Netherlands drew a Form 483 over processes for reworking nonconforming products and accepting incoming products.
The rework activities were performed without an evaluation of whether they would lead to any adverse events, and they had not received the required approval, the agency’s investigator found during an April inspection.
FMI also lacked documentation for procedures to control nonconforming products.
With regard to product acceptance activities, the inspection revealed that a sampling plan was being used for the inspection of incoming raw materials for manufacturing implantable devices for which there was no valid statistical rationale. Also, the company failed to document and maintain its acceptance activities in device history records.