FDA 483 - Paragon Medical, a division of NN Inc. - May 20, 2025

An FDA inspection of Paragon Medical, a division of NN Inc. in Indianapolis, IN, revealed deficiencies in process validation. Specifically, the firm failed to adequately validate its passivation system, including not revalidating with new worst-case materials and not challenging extreme conditions as outlined in its protocol. This indicates a significant lapse in ensuring product quality and safety.