FDA Inspection 1091111 — Amneal Pharmaceuticals Pvt. Ltd.
The FDA completed an inspection of Amneal Pharmaceuticals Pvt. Ltd. on May 24, 2019 in Bavla. 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 24, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bavla (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1163 | 21 CFR 211.28(b) | Habits of good sanitation & health |
| 8911 | 21 CFR 314.81(b)(1)(ii) | Failure to meet specifications |