FDA 483 - Jewel Precision Sheet Metal & Machining Co, Inc. - December 05, 2025

Jewel Precision Sheet Metal & Machining Co, Inc. in Cedar Grove, NJ, was cited for significant quality system deficiencies during an inspection from December 4-5, 2025. The firm failed to adequately implement corrective and preventive action procedures, specifically by not initiating a CAPA for an unreported medical device recall. Additionally, their Medical Device Reporting procedure was found to be inadequate for timely electronic submissions to the FDA.