945314
Medical Center Pharmacy, Inc. — FEI 3010536120
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 13, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cleveland, TN (United States)
Citations
| ID | CFR | Description |
|---|
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1266 | 21 CFR 211.42(d) | Penicillin processing area not kept separate |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |