FDA Inspection 718318 — Air Liquide America Specialty Gases LLC
The FDA completed an inspection of Air Liquide America Specialty Gases LLC on April 6, 2011 in Union City, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 6, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Union City, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 4576 | 21 CFR 211.192 | No written record of investigation |