FDA Inspection 1067364 — Airgas USA, LLC
The FDA completed an inspection of Airgas USA, LLC on September 28, 2018 in Cherry Hill, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 28, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cherry Hill, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1777 | 21 CFR 211.150(b) | Distribution Recall System |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3611 | 21 CFR 211.160(b)(3) | Acceptance of drug products |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |