FDA Inspection 832337 — Ipca Laboratories Limited
The FDA completed an inspection of Ipca Laboratories Limited on April 26, 2013 in Dhar. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 26, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dhar (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 4410 | 21 CFR 211.194(a)(5) | Calculations performed are in the records |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |