FDA Inspection
Airgas USA, LLCAirgas USA, LLC – FDA Inspection, May 22, 2013
Record Details
This FDA Inspection record concerns Airgas USA, LLC, with an inspection on May 22, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Airgas USA, LLC
- Inspection Date
- May 22, 2013
- Product Type
- Drugs
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ID · b47b1cd8-33eb-42f1-897c-6d1e27039192
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 830807
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.84(b)Representative Samples
- 21 CFR 211.160(b)(3)Drug products - samples representative, identified properly
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.150(b)Distribution Recall System
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.56(b)Written sanitation procedures lacking
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.80(b)Handling and Storage to Prevent Contamination
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Other FDA inspections of Airgas USA, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 8, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 9, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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