# FDA 483 - Bora Pharmaceuticals Inc. - August 30, 2022

Source: https://www.globalkeysolutions.net/records/483/bora-pharmaceuticals-inc/9793d6b9-7c22-49cc-a800-8486a8aabe45

> FDA 483 for Bora Pharmaceuticals Inc. on August 30, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bora Pharmaceuticals Inc.
- Inspection Date: 2022-08-30
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Upsher Smith Laboratories, Inc. in Maple Grove, MN, identified significant deficiencies in equipment cleaning and maintenance. The firm's procedures for cleaning, quality unit review, and post-maintenance verification were found to be inadequate, leading to concerns about potential cross-contamination and compromised product integrity. These issues were observed in the pre-weigh room and on a blender, indicating a systemic problem with maintaining a clean state.

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## Related Officers

- [Zoyinka P Fuenay](https://www.globalkeysolutions.net/people/zoyinka-p-fuenay/61427d72-58be-4aec-930f-a697366aefe1)
- [GDUFA Pharmaceutical Investigator](https://www.globalkeysolutions.net/people/kevin-p-regan/b870e1f2-017c-44ab-bc99-1ca99b474a04)
- [Ross J. Grigsby](https://www.globalkeysolutions.net/people/ross-j-grigsby/713f8252-3e41-4e6f-abea-8ca5bd48aa83)

Company: https://www.globalkeysolutions.net/companies/bora-pharmaceuticals-inc/e13118d8-e5af-4804-95e0-42699dfbf333

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d