FDA Inspection
Afton Scientific, LLCAfton Scientific, LLC – FDA Inspection, Apr 6, 2023
Record Details
This FDA Inspection record concerns Afton Scientific, LLC, with an inspection on April 6, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 34d1777e-b1ac-43ff-8d43-30aba0211933
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1202143
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.80(a)Written Procedures Not Followed
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Other FDA inspections of Afton Scientific, LLC
9| Date | Classification | Office | Project area |
|---|---|---|---|
| May 8, 2024 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 6, 2023 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| June 14, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 15, 2017 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| May 1, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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