# FDA 483 - Huvepharma Inc. - January 30, 2023

Source: https://www.globalkeysolutions.net/records/483/huvepharma-inc/d3c81349-0bef-4e83-bd73-fd3655f94695

> FDA 483 for Huvepharma Inc. on January 30, 2023. Product: veterinary. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Huvepharma Inc.
- Inspection Date: 2023-01-30
- Product Type: veterinary
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Huvepharma Inc. in Saint Louis, MO, a veterinary drug manufacturer, revealed deficiencies in preventing objectionable microorganisms in non-sterile drug products and in thoroughly investigating product specification failures. Specifically, issues included a leaking water purification system, lack of routine water testing for B. cepacia, and inadequate investigations into microbial contamination for products failing stability testing.

## Related Documents

- [483 - 2021-08-10](https://www.globalkeysolutions.net/records/483/huvepharma-inc/6866983a-b06a-4bbb-b48d-07e0dfb6f7b7)
- [483 - 2025-01-17](https://www.globalkeysolutions.net/records/483/huvepharma-inc/875d9ca9-027b-4102-83fc-d5bac90bbbe1)

## Related Officers

- [Monica E. Murie](https://www.globalkeysolutions.net/people/monica-e-murie/2db840df-d69f-4def-9830-fd461bea5507)
- [Matthew M. Schuckmann](https://www.globalkeysolutions.net/people/matthew-m-schuckmann/69dd0728-6b5d-41e7-834c-416e25a977dc)

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

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8