# FDA 483 - TRI-PAC, INC. - January 15, 2026

Source: https://www.keypedia.com/records/483/tri-pac-inc/30e9f69a-79db-4333-aabf-2dce9a0aaa82

> FDA 483 for TRI-PAC, INC. on January 15, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TRI-PAC, INC.
- Inspection Date: 2026-01-15
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: TRI-PAC, INC. in South Bend, IN, a CDMO, was cited for deficiencies in equipment cleaning and maintenance during drug product manufacturing. The inspection revealed that a filler was used for multiple batches without cleaning, and the firm lacked scientific evidence to support the dirty hold time for this equipment. This indicates a potential risk to the safety, identity, strength, quality, and purity of the drug product.

## Related Documents

- [483 - 2024-11-08](https://www.keypedia.com/records/483/tri-pac-inc/e429f7e9-f095-44f1-a725-457090904ee1)

## Related Officers

- [Beatrix D. Hippe](https://www.keypedia.com/people/beatrix-d-hippe/4a5a5258-3099-46cd-9e56-2dce60668ac5)

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

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0