FDA Inspection 1082937 — Amneal Pharmaceuticals of New York, LLC
The FDA completed an inspection of Amneal Pharmaceuticals of New York, LLC on March 18, 2019 in Hauppauge, NY. 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
- March 18, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hauppauge, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |