FDA Inspection
Midwest Fertility SpecialistsMidwest Fertility Specialists – FDA Inspection, Nov 25, 2024
Record Details
This FDA Inspection record concerns Midwest Fertility Specialists, with an inspection on November 25, 2024, issued by the Detroit District Office, covering biologics.
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ID · b8be3ff3-b2f0-491e-96ae-f7aac48bbee2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1255000
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Midwest Fertility Specialists
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 16, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 21, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 18, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 31, 2013 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 19, 2010 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Midwest Fertility Specialists
- FDA Inspection 1109705 - 2019-10-16
- FDA Inspection 1015921 - 2017-06-21
- FDA Inspection 931253 - 2015-06-18
- FDA Inspection 816819 - 2013-01-31
- FDA Inspection 660527 - 2010-04-19
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