FDA Inspection
North Florida Reproductive Biology LaboratoryNorth Florida Reproductive Biology Laboratory – FDA Inspection, Apr 12, 2024
Record Details
This FDA Inspection record concerns North Florida Reproductive Biology Laboratory, with an inspection on April 12, 2024, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- April 12, 2024
- Product Type
- Biologics
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ID · e6d8590d-0b1b-402a-b1ac-91e244f297b3
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1236567
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
5- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results
- 21 CFR 1271.55(b)(2)Listing and interpretation of CD tests performed
- 21 CFR 1271.55(b)(1)Statement re: certified testing lab
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
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Other FDA inspections of North Florida Reproductive Biology Laboratory
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 28, 2019 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 13, 2017 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 12, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 13, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for North Florida Reproductive Biology Laboratory
- FDA Inspection 1095130 - 2019-06-28
- FDA Inspection 1017722 - 2017-07-13
- FDA Inspection 917629 - 2015-03-12
- FDA Inspection 798595 - 2012-09-13
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