FDA Inspection 840930 — Viatris Pharmaceuticals LLC
The FDA completed an inspection of Viatris Pharmaceuticals LLC on Jul 16, 2013 in Vega Baja, PR. 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
- Jul 16, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Vega Baja, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1917 | 21 CFR 211.166(a)(1) | Sample size - test intervals |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |