FDA Inspection
Women's Fertility and Health CenterWomen's Fertility and Health Center – FDA Inspection, Apr 19, 2019
Record Details
This FDA Inspection record concerns Women's Fertility and Health Center, with an inspection on April 19, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · fa5a6070-9d3c-442b-b07b-03a5f5794ff4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1086823
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 1271.55(a)(1)Identification code affixed to container
- 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 Women's Fertility and Health Center
6| Date | Classification | Office | Project area |
|---|---|---|---|
| July 25, 2024 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 19, 2021 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 16, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 4, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 14, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Women's Fertility and Health Center
- FDA Inspection 1247106 - 2024-07-25
- FDA Inspection 1148838 - 2021-07-19
- FDA Inspection 1001709 - 2017-02-16
- FDA Inspection 930595 - 2015-06-04
- FDA Inspection 822961 - 2013-03-14
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