FDA Inspection 1085607 — Premcem Gums Pvt. Ltd.
The FDA completed an inspection of Premcem Gums Pvt. Ltd. on April 9, 2019 in Ahmedabad. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 9, 2019
- Fiscal Year
- 2019
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Ahmedabad (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 19045 | 21 CFR 117.160(a) | Process controls - Validation |