# FDA 483 - Upsher-Smith LLC - August 08, 2025

Source: https://www.globalkeysolutions.net/records/483/upsher-smith-llc/c4d77f7b-d6c2-471e-827e-308c939ea2c1

> FDA 483 for Upsher-Smith LLC on August 08, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Upsher-Smith LLC
- Inspection Date: 2025-08-08
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Upsher-Smith LLC identified significant deficiencies in their postmarketing adverse drug experience reporting. The firm failed to report several serious and unexpected adverse drug experiences to the FDA within the required 15-calendar-day timeframe, with delays extending over 300 days in some cases. Additionally, the firm lacked comprehensive written procedures for the surveillance and receipt of postmarketing adverse drug experiences, including those from social media, internal tracking systems, and contracted safety vendors.

## Related Documents

- [483 - 2025-08-08](https://www.globalkeysolutions.net/records/483/upsher-smith-llc/32167221-ee47-4844-9d05-f29c6332b683)

## Related Officers

- [Scott N. Lim](https://www.globalkeysolutions.net/people/scott-n-lim/d5e7745a-d804-48d1-8f3b-a94a8d4aed8a)

Company: https://www.globalkeysolutions.net/companies/upsher-smith-llc/98b07c72-437d-41b6-88ea-25acbb89effd

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