FDA Inspection 804857 — CMP Pharma Inc
The FDA completed an inspection of CMP Pharma Inc on October 24, 2012 in Farmville, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 24, 2012
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Farmville, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 3582 | 21 CFR 211.105(a) | Identification of containers, lines, equipment |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4415 | 21 CFR 211.204 | Returned drug products with doubt cast as to safety et. al. |
| 4576 | 21 CFR 211.192 | No written record of investigation |