959102
Abbott's Compounding Pharmacy, Inc. — FEI 3005529620
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 8, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Berkeley, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1433 | 21 CFR 211.42(c)(10)(iii) | Air Supply |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1869 | 21 CFR 211.94(c) | Containers & Closures Clean, Sterilized, Pyrogen-free |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1933 | 21 CFR 211.167(a) | Sterility/pyrogens - test methods written, followed |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |