FDA Inspection 1258264 — Vitae Enim Vitae Scientific, Inc.
The FDA completed an inspection of Vitae Enim Vitae Scientific, Inc. on Jan 7, 2025 in San Diego, CA. 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). 7 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 7, 2025
- Fiscal Year
- 2025
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- San Diego, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |