FDA Inspection 893386 — California Pharmacy & Compounding Center
The FDA completed an inspection of California Pharmacy & Compounding Center on August 25, 2014 in Newport Beach, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 14 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 25, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Newport Beach, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1421 | 21 CFR 211.42(c)(10) | Aseptic Processing Area |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |
| 4576 | 21 CFR 211.192 | No written record of investigation |