FDA Inspection
Midwest Fertility CenterMidwest Fertility Center – FDA Inspection, Jul 3, 2018
Record Details
This FDA Inspection record concerns Midwest Fertility Center, with an inspection on July 3, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · d298bd62-7474-44bd-9d31-bdfca92b5e32
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1058034
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
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Other FDA inspections of Midwest Fertility Center
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 6, 2023 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 2, 2013 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 14, 2010 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Midwest Fertility Center
- FDA Inspection 1210345 - 2023-06-06
- FDA Inspection 837799 - 2013-07-02
- FDA Inspection 701682 - 2010-12-14
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