FDA Inspection 666991 — NuCare Pharmaceuticals Inc
The FDA completed an inspection of NuCare Pharmaceuticals Inc on Jun 14, 2010 in Orange, CA. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 14, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Orange, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1630 | 21 CFR 211.130(b) | Unlabeled filled containers controls |
| 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. |