FDA Inspection
Michigan Reproductive and IVF Center, PLLCMichigan Reproductive and IVF Center, PLLC – FDA Inspection, Apr 27, 2023
Record Details
This FDA Inspection record concerns Michigan Reproductive and IVF Center, PLLC, with an inspection on April 27, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · ef2266cf-72c8-440f-87c6-a18e9f4629fd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1203780
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 1271.75(d)Donors with risks not determined ineligible
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.75(d)Donors with risks not determined ineligible
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Other FDA inspections of Michigan Reproductive and IVF Center, PLLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| June 3, 2026 | Not classified | Detroit District Office | Human Cellular, Tissue, and Gene Therapies |
| September 19, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 9, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 10, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 18, 2013 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Michigan Reproductive and IVF Center, PLLC
- FDA Inspection 1320288 - 2026-06-03
- FDA Inspection 1105255 - 2019-09-19
- FDA Inspection 1051882 - 2018-03-09
- FDA Inspection 960942 - 2016-02-10
- FDA Inspection 825770 - 2013-03-18
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