FDA 483 - Paradigm Packaging West, LLC - January 28, 2020

Peerless Injection Molding, LLC, a medical device manufacturer in Garden Grove, CA, was cited for significant deficiencies in its quality system. The inspection revealed inadequate procedures and documentation for complaint handling, corrective and preventive actions, and personnel training. Additionally, the firm's Medical Device Reporting procedures were found to be incomplete and not fully implemented.