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

Source: https://www.keypedia.com/records/483/upsher-smith-llc/32167221-ee47-4844-9d05-f29c6332b683

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

---

## Details

- Record Type: 483
- Company Name: Upsher-Smith LLC
- Inspection Date: 2025-08-08
- Product Type: drugs
- Office Name: San Francisco District Office
- Summary: During an inspection conducted from August 4-8, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Upsher-Smith LLC, located in Maple Grove, MN, concerning observations made during a Postmarketing Adverse Drug Experience (PADE) inspection. The primary issues identified relate to significant deficiencies in the firm's pharmacovigilance practices. The FDA noted that not all serious and unexpected adverse drug experiences were reported within the required 15-calendar-day timeframe. Several examples cited reporting delays ranging from 154 to 353 days. Furthermore, the company lacked established deviation and corrective action processes to investigate root causes for these reporting failures, with no documented investigations for late cases. A second critical observation highlighted the absence of comprehensive written procedures for the surveillance and receipt of postmarketing adverse drug experiences. This included a lack of procedures for monitoring adverse events from social media platforms, governing the centralized drug safety inbox, and detailing the use of their internal adverse event tracking system. Additionally, the firm had not developed written procedures for reconciling adverse event data with contracted safety vendors, and no such reconciliations had been performed to ensure data completeness. To address these observations, Upsher-Smith LLC is expected to implement timely reporting for all serious and unexpected adverse drug experiences, establish robust processes for identifying and correcting reporting issues, and develop comprehensive written procedures for all aspects of adverse event surveillance, tracking, and reconciliation with third-party vendors, ensuring compliance with regulatory requirements.

## Related Documents

- [483 - 2025-08-08](https://www.keypedia.com/records/483/upsher-smith-llc/c4d77f7b-d6c2-471e-827e-308c939ea2c1)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df