FDA Inspection 1236567 — North Florida Reproductive Biology Laboratory
The FDA completed an inspection of North Florida Reproductive Biology Laboratory on April 12, 2024 in Jacksonville, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- April 12, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Jacksonville, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12238 | 21 CFR 1271.55(b)(1) | Statement re: certified testing lab |
| 12239 | 21 CFR 1271.55(b)(2) | Listing and interpretation of CD tests performed |
| 12272 | 21 CFR 1271.65(b)(2) | Labeled re: biohazard, risks, test results |