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

Source: https://www.keypedia.com/records/483/jewel-precision-sheet-metal-machining-co-inc/96387496-7135-48ac-a46e-102e4787aa2a

> FDA 483 for Jewel Precision Sheet Metal & Machining Co, Inc. on December 05, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jewel Precision Sheet Metal & Machining Co, Inc.
- Inspection Date: 2025-12-05
- Product Type: device
- Office Name: New Jersey District Office
- Summary: 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.

## Related Officers

- [Colin E. Tack](https://www.keypedia.com/people/colin-e-tack/5bdbf977-d4ac-48fe-81cc-ada89379ed0d)

Company: https://www.keypedia.com/companies/jewel-precision-sheet-metal-machining-co-inc/1e6b06a1-60c9-4429-beee-18a45f423c52

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248