FDA Inspection 1093164 — Caplin Steriles Limited
The FDA completed an inspection of Caplin Steriles Limited on June 14, 2019 in Gummidipoondi. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 14, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Gummidipoondi (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |