FDA Inspection 1179132 — University Of Miami Infertility Center
The FDA completed an inspection of University Of Miami Infertility Center on Sep 9, 2022 in Miami, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Sep 9, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Miami, 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 |
| 12272 | 21 CFR 1271.65(b)(2) | Labeled re: biohazard, risks, test results |