# FDA 483 - Bora Pharmaceuticals Inc. - July 11, 2024

Source: https://www.keypedia.com/records/483/bora-pharmaceuticals-inc/e63189c9-733c-4474-89cc-4dcea8d6dfe6

> FDA 483 for Bora Pharmaceuticals Inc. on July 11, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bora Pharmaceuticals Inc.
- Inspection Date: 2024-07-11
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Upsher Smith Laboratories, LLC in Maple Grove, MN, revealed significant deficiencies in their manufacturing processes. Observations included inadequate testing of drug product components for harmful substances like diethylene glycol, and failure to follow written procedures for equipment cleaning and maintenance. Additionally, the firm's batch records lacked proper documentation for equipment identification, indicating a lack of control over critical aspects of drug manufacturing and quality.

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## Related Officers

- [Beatrix D. Hippe](https://www.keypedia.com/people/beatrix-d-hippe/4a5a5258-3099-46cd-9e56-2dce60668ac5)
- [Soyinka S. Eneng](https://www.keypedia.com/people/soyinka-s-eneng/a7f69c63-1beb-4c59-9ccd-6e35c49a10c5)
- [Investigator](https://www.keypedia.com/people/rafeeq-a-habeeb/ac58c0b7-bd42-4037-8ccb-bf0351b7744f)

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

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