FDA Inspection 1029733 — Amneal Pharmaceuticals, Llc
The FDA completed an inspection of Amneal Pharmaceuticals, Llc on October 25, 2017 in Paterson, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 25, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Paterson, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1224 | 21 CFR 211.67(b)(6) | Cleaning SOP/inspection |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |