FDA Inspection 1229351 — Upsher-Smith Laboratories, LLC
The FDA completed an inspection of Upsher-Smith Laboratories, LLC on August 8, 2025 in Maple Grove, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 8, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Maple Grove, MN (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |
| 6732 | 21 CFR 314.80(c)(1)(i) | Late submission of 15-day report |