483
Paragon Medical, a division of NN Inc.Paragon Medical, a division of NN Inc. – FDA 483, May 20, 2025
Record Details
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.
- Office
- Detroit District Office
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ID · 1edef631-3be9-49ae-a90e-ae2a701e1f5b
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