FDA Inspection 1009631 — Sidmak Laboratories India Pvt Ltd
The FDA completed an inspection of Sidmak Laboratories India Pvt Ltd on March 31, 2017 in Dehradun. 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
- March 31, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dehradun (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1496 | 21 CFR 211.122(a) | Sampling/testing of labeling/packaging materials |
| 4344 | 21 CFR 211.160(b)(1) | Sampling and testing procedures described |
| 4576 | 21 CFR 211.192 | No written record of investigation |