FDA Inspection 749704 — Airway Oxygen Inc.
The FDA completed an inspection of Airway Oxygen Inc. on October 14, 2011 in Lansing, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 14, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lansing, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 4341 | 21 CFR 211.142(a) | Quarantine - written procedures |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |