FDA Inspection 1046054 — Alkem Laboratories Limited
The FDA completed an inspection of Alkem Laboratories Limited on March 27, 2018 in Daman. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 13 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 27, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Daman (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3582 | 21 CFR 211.105(a) | Identification of containers, lines, equipment |
| 3586 | 21 CFR 211.110(a)(1) | Tablet or capsule weight variation |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4364 | 21 CFR 211.176 | Failing to test for penicillin cross-contamination |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |