FDA Inspection 1195234 — AgroChem USA, LLC
The FDA completed an inspection of AgroChem USA, LLC on January 13, 2023 in Saratoga Springs, NY. 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
- January 13, 2023
- Fiscal Year
- 2023
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Saratoga Springs, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |