# FDA 483 - Omega Packaging Corp - November 17, 2022

Source: https://www.globalkeysolutions.net/records/483/omega-packaging-corp/65cc12f1-a932-46f1-b4ae-a10c0db81db0

> FDA 483 for Omega Packaging Corp on November 17, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Omega Packaging Corp
- Inspection Date: 2022-11-17
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Omega Packaging Corp in Totowa, NJ, a manufacturer of hand sanitizer products, revealed significant deficiencies across multiple systems. The firm failed to establish and document adequate test methods, maintain a reliable stability program, ensure proper laboratory record review, and implement approved quality control procedures. Critical issues also included a lack of data integrity controls, insufficient employee training, unvalidated manufacturing processes and water systems, and unvalidated cleaning procedures for equipment.

## Related Documents

- [WARNING_LETTER - 2022-11-17](https://www.globalkeysolutions.net/records/warning_letter/omega-packaging-corp/bc18fc71-e16a-4819-ba01-5a50ded07e0c)

## Related Officers

- [Rose L. Jean-Mary](https://www.globalkeysolutions.net/people/rose-l-jean-mary/398483f5-12f7-429b-8a13-c068b41ff3ed)
- [investigator](https://www.globalkeysolutions.net/people/anthony-j-donato/a6dd6e14-529e-4b23-9b5f-02c88afb80ae)

Company: https://www.globalkeysolutions.net/companies/omega-packaging-corp/f4c248ca-7c0e-47ec-97b1-f297db14b3cc

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