# FDA 483 - TRI-PAC, INC. - November 08, 2024

Source: https://www.keypedia.com/records/483/tri-pac-inc/e429f7e9-f095-44f1-a725-457090904ee1

> FDA 483 for TRI-PAC, INC. on November 08, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TRI-PAC, INC.
- Inspection Date: 2024-11-08
- Product Type: drugs
- Office Name: Detroit District Office
- Summary: An FDA inspection of TRI-PAC, INC. in South Bend, IN, revealed a significant issue regarding the sampling of incoming drug components. The firm failed to conduct sufficient identity testing for incoming shipments of Glycerin, a high-risk component for Ethylene Glycol and Diethylene Glycol contamination. This deficiency impacts multiple products manufactured by the firm, including Antimicrobial Foam Skin Cleanser and Moisturizing Foam Hand Sanitizer.

## Related Officers

- [Nicholas J. Presto](https://www.keypedia.com/people/nicholas-j-presto/2ecdd573-6662-4d07-b93c-ddb9c603bcfa)

Company: https://www.keypedia.com/companies/tri-pac-inc/d16a6f69-6300-4423-a735-6a480b227e35

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03