FDA Inspection 1090627 — Aurobindo Pharma Ltd
The FDA completed an inspection of Aurobindo Pharma Ltd on May 24, 2019 in Medchal. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 24, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Medchal (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1768 | 21 CFR 211.137(b) | Storage conditions |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3623 | 21 CFR 211.170(a) | Active ingredient retained sample kept |
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |
| 4382 | 21 CFR 211.198(b)(2) | Written record of complaint to include findings, follow-up |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |