FDA Inspection 848527 — California Pharmaceuticals LLC
The FDA completed an inspection of California Pharmaceuticals LLC on Sep 6, 2013 in Camarillo, 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 6, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Camarillo, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1803 | 21 CFR 211.84(b) | Representative Samples Criteria |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4351 | 21 CFR 211.160(b)(3) | Drug products - samples representative, identified properly |
| 4356 | 21 CFR 211.166(b) | Tentative expiration date |