1079024
Dr. Reddy's Laboratories Ltd. — FEI 3002949099
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 8, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Medchal-Malkajgiri District (India)
Citations
| ID | CFR | Description |
|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1086 | 21 CFR 211.22(b) | Adequate lab facilities not available |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3555 | 21 CFR 211.48(b) | Drains--Size, Back-siphonage Prevention |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 4347 | 21 CFR 211.160(b)(2) | In process materials - conformance to written specs |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |
| 4418 | 21 CFR 211.42(b) | Adequate space lacking to prevent mix-ups and contamination |