FDA Inspection
Western Fertility InstituteWestern Fertility Institute – FDA Inspection, Dec 8, 2023
Record Details
This FDA Inspection record concerns Western Fertility Institute, with an inspection on December 8, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 6fec11e7-8170-4047-8bcf-f71f95ff12b6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1224774
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 1271.75(d)Donors with risks not determined ineligible
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.47(a)Design of procedures to ensure compliance
- 21 CFR 1271.50(a)Responsible person to determine, document
- 21 CFR 1271.47(a)Design of procedures to ensure compliance
- 21 CFR 1271.50(a)Responsible person to determine, document
- 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 Western Fertility Institute
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 19, 2018 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 21, 2017 | OAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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