FDA Inspection 1106975 — Airgas USA, LLC
The FDA completed an inspection of Airgas USA, LLC on October 18, 2019 in Miami, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 18, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4369 | 21 CFR 211.188(b)(11) | Identification of persons involved, each significant step |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |