FDA Inspection 990477 — Viatris Pharmaceuticals LLC
The FDA completed an inspection of Viatris Pharmaceuticals LLC on July 26, 2016 in Vega Baja, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 26, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Vega Baja, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |