# FDA 483 - Bora Pharmaceuticals Inc. - December 19, 2018

Source: https://www.globalkeysolutions.net/records/483/bora-pharmaceuticals-inc/2c512f09-ec77-4928-90d4-05eb9d25d948

> FDA 483 for Bora Pharmaceuticals Inc. on December 19, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bora Pharmaceuticals Inc.
- Inspection Date: 2018-12-19
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: Upsher Smith Laboratories, Inc. in Maple Grove, MN, was inspected by the FDA from December 11-19, 2018. The inspection revealed significant deficiencies in laboratory controls, specifically regarding the establishment of scientifically sound test procedures and the cleanliness of volumetric glassware. These issues indicate a failure to assure drug products conform to appropriate standards of identity, strength, quality, and purity.

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## Related Officers

- [Courtney R. Ingalsbe](https://www.globalkeysolutions.net/people/courtney-r-ingalsbe/534b281d-a2bf-473c-b17a-dc1ff42147df)
- [Ross J. Grigsby](https://www.globalkeysolutions.net/people/ross-j-grigsby/713f8252-3e41-4e6f-abea-8ca5bd48aa83)
- [Scott A. Golladay](https://www.globalkeysolutions.net/people/scott-a-golladay/78c90066-7212-4442-900c-5cdcb677aeec)

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