FDA Inspection
Florida Institute for Reproductive Sciences and TechnologiesFlorida Institute for Reproductive Sciences and Technologies – FDA Inspection, Sep 9, 2014
Record Details
This FDA Inspection record concerns Florida Institute for Reproductive Sciences and Technologies, with an inspection on September 9, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 9, 2014
- Product Type
- Biologics
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ID · 46f8e5ff-f4ec-4f20-9b27-36386c2b1e09
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 895007
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
5- 21 CFR 1271.55(d)(1)(iii)Documentation--determination, by whom, date
- 21 CFR 1271.47(b)Review and approval of procedures
- 21 CFR 1271.75(a)(2)Risks associated with xenotransplantation
- 21 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results
- 21 CFR 1271.55(c)Name and personal info on accompanying records
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Other FDA inspections of Florida Institute for Reproductive Sciences and Technologies
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 19, 2025 | Not classified | Florida District Office | |
| October 6, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| August 11, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 10, 2017 | OAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 22, 2016 | OAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Florida Institute for Reproductive Sciences and Technologies
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- FDA Inspection 1028934 - 2017-08-11
- FDA Inspection 1002581 - 2017-02-10
- FDA Inspection 972752 - 2016-01-22
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