# FDA 483 - Jones Healthcare Group - Packaging Services, Inc. - November 18, 2022

Source: https://www.globalkeysolutions.net/records/483/jones-healthcare-group-packaging-services-inc/7c069a37-0afa-451f-b5b9-3e7fb9927ac0

> FDA 483 for Jones Healthcare Group - Packaging Services, Inc. on November 18, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jones Healthcare Group - Packaging Services, Inc.
- Inspection Date: 2022-11-18
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Jones Healthcare Group - Packaging Services, Inc. in Brampton revealed significant deficiencies in their quality system, material handling, equipment management, and computer system controls. The firm, a contract manufacturer for packaging, failed to ensure proper procedure approval, material identity testing, equipment cleaning validation, appropriate equipment design, and computer system accuracy. These issues indicate a lack of robust controls necessary for drug product manufacturing and packaging.

## Related Officers

- [Teresa I. Navas](https://www.globalkeysolutions.net/people/teresa-i-navas/43f747c0-18c2-4630-bab9-936204aa93aa)

Company: https://www.globalkeysolutions.net/companies/jones-healthcare-group-packaging-services-inc/376c43aa-5407-4fd1-a46f-730f07a8fdd2

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1