FDA Inspection 643297 — ANI Pharmaceuticals, Inc.
The FDA completed an inspection of ANI Pharmaceuticals, Inc. on January 29, 2010 in Baudette, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 29, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Baudette, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |