FDA Inspection 1046492 — Amneal Oncology Private Limited
The FDA completed an inspection of Amneal Oncology Private Limited on March 15, 2018 in Hyderabad. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 15, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hyderabad (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |