FDA Inspection 1262267 — AG Essence, Inc.
The FDA completed an inspection of AG Essence, Inc. on February 26, 2025 in Sandston, VA. 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
- February 26, 2025
- Fiscal Year
- 2025
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Sandston, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 3567 | 21 CFR 211.84(d)(2) | Component identification test |