# FDA 483 - Upsher Smith Laboratories, Inc. - December 19, 2018

Source: https://www.globalkeysolutions.net/records/483/upsher-smith-laboratories-inc/8cbf2227-5dbd-45c8-85eb-3b14fc392767

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

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## Details

- Record Type: 483
- Company Name: Upsher Smith Laboratories, Inc.
- Inspection Date: 2018-12-19
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: The FDA inspected Upsher Smith Laboratories, Inc. in Plymouth, MN, identifying significant deficiencies in quality control unit procedures, batch production records, equipment cleaning, and dietary supplement quality. The firm failed to follow written change control procedures, ensure component traceability for drug products, adequately define equipment hold times, and maintain proper records, leading to the release of sub-potent niacin dietary supplements.

## 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/upsher-smith-laboratories-inc/9ce8b2aa-556d-4521-b72d-4e5c8bb5bd9e

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