FDA Inspection 1114641 — Steril-Gene Life Sciences Private Ltd
The FDA completed an inspection of Steril-Gene Life Sciences Private Ltd on Dec 10, 2019 in Puducherry. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Veterinary.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 10, 2019
- Fiscal Year
- 2020
- Product Type
- Veterinary
- Project Area
- Pre-Approval Eval. of Animal Drugs and Food Additives
- Location
- Puducherry (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1224 | 21 CFR 211.67(b)(6) | Cleaning SOP/inspection |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |