FDA Inspection 1205086 — American Distribution and Manufacturing Co, LLC
The FDA completed an inspection of American Distribution and Manufacturing Co, LLC on May 12, 2023 in Cottage Grove, MN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 12, 2023
- Fiscal Year
- 2023
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Cottage Grove, MN (United States)
Additional Details
FSVP
Citations
| ID | CFR | Description |
|---|---|---|
| 22405 | 21 CFR 1.502(a) | Develop FSVP |
| 22416 | 21 CFR 1.504(a) | Hazard analysis written |
| 22429 | 21 CFR 1.505(a)(2) | Evaluation - performance, risk |
| 22439 | 21 CFR 1.506(a)(1) | Approved supplier procedures - importer established |
| 22442 | 21 CFR 1.506(b) | Supplier verification - establish written procedures |
| 22444 | 21 CFR 1.506(d)(1)(i) | Verification activity assurance |
| 22452 | 21 CFR 1.506(e)(1) | Verification activity before import, periodically |