FDA Inspection
Airgas USA, LLCAirgas USA, LLC – FDA Inspection, Sep 30, 2024
Record Details
This FDA Inspection record concerns Airgas USA, LLC, with an inspection on September 30, 2024, issued by the Baltimore District Office, covering human drugs.
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ID · 826b52d4-b64c-4c74-93d4-6788d1105858
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1250811
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.160(b)(3)Acceptance of drug products
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.182Written records kept in individual logs
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Other FDA inspections of Airgas USA, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 30, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 11, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Airgas USA, LLC
- FDA Inspection 1041050 - 2018-01-30
- FDA Inspection 582789 - 2009-05-11
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