FDA Inspection 827045 — Clinical Specialties Compounding Pharmacy
The FDA completed an inspection of Clinical Specialties Compounding Pharmacy on April 2, 2013 in Augusta, GA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 2, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Augusta, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1136 | 21 CFR 211.25(c) | Inadequate number of personnel |
| 1174 | 21 CFR 211.42(b) | Product flow through building is inadequate |
| 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 |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2569 | 21 CFR 211.198(b) | Maintenance of Complaint File |
| 4338 | 21 CFR 211.150(b) | Recall facilitation |