FDA Inspection
American Distribution and Manufacturing Co, LLCFDA Inspection 1205086 - American Distribution and Manufacturing Co, LLC - May 12, 2023
Record Details
This FDA Inspection record concerns American Distribution and Manufacturing Co, LLC, with an inspection on May 12, 2023, issued by the Center for Veterinary Medicine, covering veterinary.
- Inspection Date
- May 12, 2023
- Product Type
- Veterinary
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ID · ea17ffe1-e8c3-4c0d-a05d-98c4fe9d8613
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1205086
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
14- 21 CFR 1.506(e)(1)Verification activity before import, periodically
- 21 CFR 1.506(d)(1)(i)Verification activity assurance
- 21 CFR 1.502(a)Develop FSVP
- 21 CFR 1.505(a)(2)Evaluation - performance, risk
- 21 CFR 1.506(b)Supplier verification - establish written procedures
- 21 CFR 1.506(a)(1)Approved supplier procedures - importer established
- 21 CFR 1.504(a)Hazard analysis written
- 21 CFR 1.502(a)Develop FSVP
- 21 CFR 1.504(a)Hazard analysis written
- 21 CFR 1.505(a)(2)Evaluation - performance, risk
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Other FDA inspections of American Distribution and Manufacturing Co, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 13, 2026 | Not classified | Minneapolis District Office | |
| May 30, 2024 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| October 5, 2023 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
Other documents for American Distribution and Manufacturing Co, LLC
- FDA Inspection 1298688 - 2026-01-13
- FDA Inspection 1239833 - 2024-05-30
- FDA Inspection 1220175 - 2023-10-05
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