FDA Inspection 667617 — CMS Imaging, Inc.
The FDA completed an inspection of CMS Imaging, Inc. on Jun 18, 2010 in Orange Park, 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 18, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Orange Park, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1777 | 21 CFR 211.150(b) | Distribution Recall System |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2034 | 21 CFR 211.194(d) | Laboratory equipment calibration records |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |