FDA Inspection 1136685 — Neogen Corporation
The FDA completed an inspection of Neogen Corporation on March 16, 2021 in Lexington, KY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 16, 2021
- Fiscal Year
- 2021
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Lexington, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1506 | 21 CFR 211.122(e) | Destruction of obsolete labeling |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |