FDA Inspection
Western Fertility InstituteWestern Fertility Institute – FDA Inspection, Oct 19, 2018
Record Details
This FDA Inspection record concerns Western Fertility Institute, with an inspection on October 19, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 61dfa225-853c-4599-81a1-e0f6b513352a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1070337
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 1271.85(b)(2)SOP for release; reactive for CMV
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.90(c)Eligibility not required--warning labels
- 21 CFR 1271.47(a)Procedures for all other requirements
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Other FDA inspections of Western Fertility Institute
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 8, 2023 | 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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