FDA Inspection 972752 — Florida Institute for Reproductive Sciences and Technologies
The FDA completed an inspection of Florida Institute for Reproductive Sciences and Technologies on January 22, 2016 in Weston, FL. 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: Biologics.
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 |