FDA Inspection 828673 — Airway Oxygen Inc.
The FDA completed an inspection of Airway Oxygen Inc. on April 24, 2013 in Kalamazoo, MI. 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 24, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Kalamazoo, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1726 | 21 CFR 211.86 | Rotation of components/containers/closures |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |