FDA Inspection 670814 — Ipca Laboratories Limited
The FDA completed an inspection of Ipca Laboratories Limited on May 28, 2010 in Silvassa. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 28, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Silvassa (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 2567 | 21 CFR 211.198(a) | Adverse Drug Experience |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3591 | 21 CFR 211.110(b) | In-process materials specifications |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |