FDA Inspection 1089865 — Alkem Laboratories Limited
The FDA completed an inspection of Alkem Laboratories Limited on May 17, 2019 in Tehsil Nalagarh, Baddi. 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
- May 17, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tehsil Nalagarh, Baddi (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 |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3607 | 21 CFR 211.160(b)(2) | Acceptance of in-process materials |