FDA Inspection 895007 — Florida Institute For Reproductive Sciences And Technologies
The FDA completed an inspection of Florida Institute For Reproductive Sciences And Technologies on Sep 9, 2014 in Weston, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 9, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Weston, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12223 | 21 CFR 1271.47(b) | Review and approval of procedures |
| 12242 | 21 CFR 1271.55(c) | Name and personal info on accompanying records |
| 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 |
| 12278 | 21 CFR 1271.75(a)(2) | Risks associated with xenotransplantation |