FDA Inspection
Institute For Women's Health - Advanced Fertility CenterInstitute For Women's Health - Advanced Fertility Center – FDA Inspection, Jun 5, 2014
Record Details
This FDA Inspection record concerns Institute For Women's Health - Advanced Fertility Center, with an inspection on June 5, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- June 5, 2014
- Product Type
- Biologics
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ID · d645e1ad-17b9-4d91-8cf3-39e433fc3636
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 882370
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 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)Testing, screening, donor eligibility procedures
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Other FDA inspections of Institute For Women's Health - Advanced Fertility Center
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 21, 2020 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 17, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 2, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Institute For Women's Health - Advanced Fertility Center
- FDA Inspection 1116513 - 2020-01-21
- FDA Inspection 1024125 - 2017-08-17
- FDA Inspection 766224 - 2012-02-02
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