483
Jewel Precision Sheet Metal & Machining Co, Inc.FDA 483 - Jewel Precision Sheet Metal & Machining Co, Inc. - December 05, 2025
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Record Details
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.
- Inspection Date
- December 5, 2025
- Product Type
- Device
- Person
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ID · 96387496-7135-48ac-a46e-102e4787aa2a