# FDA 483 - George Taub Products & Fusion Co., Inc. - November 20, 2024

Source: https://www.globalkeysolutions.net/records/483/george-taub-products-fusion-co-inc/a882e591-3821-4798-8a7b-20c1c654bacd

> FDA 483 for George Taub Products & Fusion Co., Inc. on November 20, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: George Taub Products & Fusion Co., Inc.
- Inspection Date: 2024-11-20
- Product Type: device
- Office Name: New Jersey District Office
- Summary: George Taub Products & Fusion Co., Inc. in Jersey City, NJ, was inspected and cited for numerous deficiencies in its quality system. The inspection revealed significant issues across device master records, production processes, personnel training, CAPA documentation, design risk analysis, MDR procedures, supplier control, quality audits, and management reviews. These observations indicate a broad lack of adherence to established procedures and regulatory requirements for medical device manufacturing.

## Related Officers

- [Esteban Beltran](https://www.globalkeysolutions.net/people/esteban-beltran/9a9bf6b2-ecdf-494c-82f4-5ef5932d629a)

Company: https://www.globalkeysolutions.net/companies/george-taub-products-fusion-co-inc/a61b9b4e-ea29-4a91-aa50-c5912818e873

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