FDA Inspection
Institute For Women's Health - Advanced Fertility CenterInstitute For Women's Health - Advanced Fertility Center – FDA Inspection, Feb 2, 2012
Record Details
This FDA Inspection record concerns Institute For Women's Health - Advanced Fertility Center, with an inspection on February 2, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 2, 2012
- Product Type
- Biologics
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ID · c7a60ea0-a33d-4c47-807b-f6f882ae269b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 766224
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.80(c)Kits not FDA approved, specifically labeled
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.47(a)Procedures for all other requirements
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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 |
| June 5, 2014 | 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 882370 - 2014-06-05
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