FDA Inspection 1277270 — Surmasis Pharmaceutical, LLC
The FDA completed an inspection of Surmasis Pharmaceutical, LLC on Aug 1, 2025 in Des Moines, IA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 1, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Des Moines, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 2293 | 21 CFR 820.20(d) | Quality plan |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 4576 | 21 CFR 211.192 | No written record of investigation |