FDA Inspection 721586 — Camelot Healthcare
The FDA completed an inspection of Camelot Healthcare on Apr 29, 2011 in Winter Haven, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 29, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Winter Haven, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1722 | 21 CFR 211.134(a) | Correct labels during finishing operations |
| 2569 | 21 CFR 211.198(b) | Maintenance of Complaint File |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 4302 | 21 CFR 211.56(b) | Written sanitation procedures not followed |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |