FDA Inspection
Afton Scientific, LLCAfton Scientific, LLC – FDA Inspection, Oct 6, 2023
Record Details
This FDA Inspection record concerns Afton Scientific, LLC, with an inspection on October 6, 2023, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · 7a563c9f-cf1f-4d4f-89dd-36f153aa9827
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1219743
- FDA center
- Foods & Cosmetics
- Project area
- Foodborne Biological Hazards
- Outcome
- Form 483 issued
FDA Citations
16- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.160(b)(3)Drug products - samples representative, identified properly
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 117.135(c)(3)Sanitation preventive controls - Appropriate (Adequate)
- 21 CFR 117.410(c)Supply-chain program - Assurance (Adequate)
- 21 CFR 117.135(c)(3)Sanitation preventive controls - Appropriate (Adequate)
- 21 CFR 117.410(c)Supply-chain program - Assurance (Adequate)
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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 |
| April 6, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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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