FDA Inspection
Florida Institute for Reproductive MedicineFlorida Institute for Reproductive Medicine – FDA Inspection, Nov 7, 2017
Record Details
This FDA Inspection record concerns Florida Institute for Reproductive Medicine, with an inspection on November 7, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- November 7, 2017
- Product Type
- Biologics
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ID · 602bffe3-0655-4312-963c-96de1c8d3fdd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1030849
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1271.50(b)(2)Donor testing not negative for CD agents
- 21 CFR 1271.80(b)Specimen collections not timely
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Other FDA inspections of Florida Institute for Reproductive Medicine
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 7, 2024 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 6, 2020 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 10, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 11, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Florida Institute for Reproductive Medicine
- FDA Inspection 1230530 - 2024-02-07
- FDA Inspection 1119010 - 2020-01-06
- FDA Inspection 947937 - 2015-11-10
- FDA Inspection 839966 - 2013-07-11
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