FDA 483 - Generica Medical International - March 15, 2023

Generica Medical International, a medical device manufacturer in La Verne, CA, was inspected by the FDA, revealing two significant observations. The firm failed to adequately establish procedures for design control, specifically lacking documentation for design review and transfer for ENFit Connectors. Additionally, the inspection found inadequate procedures for training and identifying training needs, with no documented training records for an individual performing acceptance activities.