FDA Inspection
Afton Scientific, LLCAfton Scientific, LLC – FDA Inspection, Jun 14, 2019
Record Details
This FDA Inspection record concerns Afton Scientific, LLC, with an inspection on June 14, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · b3632484-cce6-4e6e-9f90-21df1d616bdc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1092986
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(1)Sample identification and other information
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.42(c)(10)Aseptic Processing Area
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully 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 |
| April 6, 2023 | 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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