FDA Inspection 669080 — Aerocare Holdings Inc
The FDA completed an inspection of Aerocare Holdings Inc on June 18, 2010 in Denver, CO. 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
- June 18, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Denver, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 4368 | 21 CFR 211.188(b)(12) | Investigations made into any unexplained discrepancy |