972752
Florida Institute for Reproductive Sciences and Technologies — FEI 3004516706
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 22, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Weston, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 12223 | 21 CFR 1271.47(b) | Review and approval of procedures |
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12242 | 21 CFR 1271.55(c) | Name and personal info on accompanying records |
| 12245 | 21 CFR 1271.55(d)(1)(ii) | Results, interpretation of CD screening |
| 12246 | 21 CFR 1271.55(d)(1)(iii) | Documentation--determination, by whom, date |
| 12272 | 21 CFR 1271.65(b)(2) | Labeled re: biohazard, risks, test results |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12282 | 21 CFR 1271.75(d) | Donors with risks not determined ineligible |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |
| 12490 | 21 CFR 1271.85(b)(1) | Cell-associated CD |
| 12492 | 21 CFR 1271.85(a) | Infection with communicable disease agents |