FDA Inspection 1169446 — Aurobindo Pharma Limited
The FDA completed an inspection of Aurobindo Pharma Limited on May 10, 2022 in Jedcherla Mandal, Mahabubnagar. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 10, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Jedcherla Mandal, Mahabubnagar (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |