FDA Inspection 1030849 — Florida Institute for Reproductive Medicine
The FDA completed an inspection of Florida Institute for Reproductive Medicine on November 7, 2017 in Jacksonville, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- November 7, 2017
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Jacksonville, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12232 | 21 CFR 1271.50(b)(2) | Donor testing not negative for CD agents |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |