FDA Inspection 830807 — Airgas USA, LLC
The FDA completed an inspection of Airgas USA, LLC on May 22, 2013 in Billerica, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 22, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Billerica, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1777 | 21 CFR 211.150(b) | Distribution Recall System |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |
| 4351 | 21 CFR 211.160(b)(3) | Drug products - samples representative, identified properly |