FDA Inspection
Airgas USA, LLCAirgas USA, LLC – FDA Inspection, Sep 28, 2018
Record Details
This FDA Inspection record concerns Airgas USA, LLC, with an inspection on September 28, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 5ac98ff6-c8d2-4f4b-844f-f9a1fa580c87
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1067364
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.160(b)(3)Acceptance of drug products
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.150(b)Distribution Recall System
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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Other FDA inspections of Airgas USA, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 28, 2018 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| May 21, 2013 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
Other documents for Airgas USA, LLC
- FDA Inspection 1057009 - 2018-03-28
- FDA Inspection 832498 - 2013-05-21
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