FDA Inspection 900112 — California Pharmacy & Compounding Center
The FDA completed an inspection of California Pharmacy & Compounding Center on October 17, 2014 in Newport Beach, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 17, 2014
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Newport Beach, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |