FDA Inspection 713372 — Airgas USA, LLC
The FDA completed an inspection of Airgas USA, LLC on Feb 22, 2011 in Harvey, LA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 22, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Harvey, LA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |