FDA Inspection
Florida Institute for Reproductive Sciences and TechnologiesFlorida Institute for Reproductive Sciences and Technologies – FDA Inspection, Jan 22, 2016
Record Details
This FDA Inspection record concerns Florida Institute for Reproductive Sciences and Technologies, with an inspection on January 22, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- January 22, 2016
- Product Type
- Biologics
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ID · 5d285aab-03f7-4ba4-8eb2-8535636ddc03
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 972752
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
11- 21 CFR 1271.55(d)(1)(ii)Results, interpretation of CD screening
- 21 CFR 1271.55(d)(1)(iii)Documentation--determination, by whom, date
- 21 CFR 1271.47(b)Review and approval of procedures
- 21 CFR 1271.85(b)(1)Cell-associated CD
- 21 CFR 1271.80(b)Specimen collections not timely
- 21 CFR 1271.75(d)Donors with risks not determined ineligible
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.85(a)Infection with communicable disease agents
- 21 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results
- 21 CFR 1271.55(c)Name and personal info on accompanying records
Showing 10 of 11 citations.
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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 |
| 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
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- FDA Inspection 1181247 - 2022-10-06
- FDA Inspection 1028934 - 2017-08-11
- FDA Inspection 1002581 - 2017-02-10
- FDA Inspection 895007 - 2014-09-09
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