# FDA 483 - Huvepharma Inc. - January 17, 2025

Source: https://www.keypedia.com/records/483/huvepharma-inc/875d9ca9-027b-4102-83fc-d5bac90bbbe1

> FDA 483 for Huvepharma Inc. on January 17, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Huvepharma Inc.
- Inspection Date: 2025-01-17
- Product Type: drugs
- Office Name: Kansas City District Office
- Summary: Huvepharma Inc., a drug manufacturer in Saint Louis, MO, was cited for three observations during an FDA inspection. The observations relate to inadequate master production records for lot and expiry codes, failure of the quality control unit to follow procedures during stability testing, and insufficient testing of components for harmful impurities. These issues indicate significant concerns regarding quality control and manufacturing process adherence.

## Related Documents

- [483 - 2021-08-10](https://www.keypedia.com/records/483/huvepharma-inc/6866983a-b06a-4bbb-b48d-07e0dfb6f7b7)
- [483 - 2023-01-30](https://www.keypedia.com/records/483/huvepharma-inc/d3c81349-0bef-4e83-bd73-fd3655f94695)

## Related Officers

- [Matthew M. Schuckmann](https://www.keypedia.com/people/matthew-m-schuckmann/69dd0728-6b5d-41e7-834c-416e25a977dc)

Company: https://www.keypedia.com/companies/huvepharma-inc/4352a4d7-a7f5-4a0b-a3c1-13a90edd69b8

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79