FDA Inspection 1250811 — Airgas USA, LLC
The FDA completed an inspection of Airgas USA, LLC on September 30, 2024 in Hyattsville, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 30, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hyattsville, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 3611 | 21 CFR 211.160(b)(3) | Acceptance of drug products |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |