# FDA 483 - JAK Diversified II Inc. - January 31, 2011

Source: https://www.globalkeysolutions.net/records/483/jak-diversified-ii-inc/06ca9dd4-5dbf-4d1f-9e7b-57de6d5e42fa

> FDA 483 for JAK Diversified II Inc. on January 31, 2011. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: JAK Diversified II Inc.
- Inspection Date: 2011-01-31
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of JAK Diversified, L.L.C. DBA Multi-Pak Packaging, L.L.C. in Fairfield, NJ, an OTC repacker, revealed significant deficiencies in their manufacturing and quality control systems. The firm lacked essential written procedures for process and cleaning validations, failed to retain required batch records, and did not adequately manage reprocessing or conduct annual visual examinations of retain samples. Additionally, the company failed to provide documented cGMP training for its employees.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/stephen-j-mottola/a35bf779-9edb-40a3-93c8-1ac43808dccf)
- [Executive Director](https://www.globalkeysolutions.net/people/alberto-a-viciedo/1babb43c-62f3-45ad-8669-d12d6d36b395)

Company: https://www.globalkeysolutions.net/companies/jak-diversified-ii-inc/d09785e8-aaf2-4210-bcad-7454770e38b9

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