Anaheim, California-based Anacom MedTek hadn’t established procedures for finished device acceptance, for acceptance of incoming product or for CAPA activities, an FDA inspection found.

Multiple repeat deficiencies related to medical device reporting, CAPAs, validation procedures and acceptance activities were uncovered during an FDA inspection of General Medical Company’s Jacksonville, Florida manufacturing facility.

Failure to establish procedures for design control and to document control procedures and acceptance activity procedures were just a few of the 483 observations cited for device specification developer and repackager Web 2U Com during an inspection of its Fort Lauderdale, Florida plant.