669080
Aerocare Holdings Inc — FEI 3008387119
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 |