FDA Inspection
Florida Institute for Reproductive Sciences and TechnologiesFlorida Institute for Reproductive Sciences and Technologies – FDA Inspection, Feb 10, 2017
Record Details
This FDA Inspection record concerns Florida Institute for Reproductive Sciences and Technologies, with an inspection on February 10, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 10, 2017
- Product Type
- Biologics
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ID · 2ff6c532-f6b9-45a6-a4e5-d86228fbb9d1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1002581
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 1271.55(d)(1)(iii)Documentation--determination, by whom, date
- 21 CFR 1271.50(b)(1)Donor screening standards
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.150(c)(1)(iii)Ensurane of compliance
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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 |
| January 22, 2016 | OAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 9, 2014 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Florida Institute for Reproductive Sciences and Technologies
- FDA Inspection 1280427 - 2025-08-19
- FDA Inspection 1181247 - 2022-10-06
- FDA Inspection 1028934 - 2017-08-11
- FDA Inspection 972752 - 2016-01-22
- FDA Inspection 895007 - 2014-09-09
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