FDA Inspection 1002581 — Florida Institute for Reproductive Sciences and Technologies
The FDA completed an inspection of Florida Institute for Reproductive Sciences and Technologies on February 10, 2017 in Weston, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 10, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Weston, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12231 | 21 CFR 1271.50(b)(1) | Donor screening standards |
| 12246 | 21 CFR 1271.55(d)(1)(iii) | Documentation--determination, by whom, date |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12301 | 21 CFR 1271.150(c)(1)(iii) | Ensurane of compliance |