FDA Inspection 673459 — Airgas USA, LLC
The FDA completed an inspection of Airgas USA, LLC on July 19, 2010 in Chattanooga, TN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 19, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chattanooga, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4319 | 21 CFR 211.84(d)(5) | Exam for Filth, Insects, Extraneous Adulterants |
| 4369 | 21 CFR 211.188(b)(11) | Identification of persons involved, each significant step |