906086
Absolute Pharmacy, LLC — FEI 3011116100
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 19, 2014
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lutz, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 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 |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1849 | 21 CFR 211.84(d)(6) | Objectionable microbiological contamination |
| 1870 | 21 CFR 211.94(d) | Written Procedures to Remove Pyrogens |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |