FDA Inspection
Center for Advanced Reproductive EndocrinologyCenter for Advanced Reproductive Endocrinology – FDA Inspection, Jul 25, 2014
Record Details
This FDA Inspection record concerns Center for Advanced Reproductive Endocrinology, with an inspection on July 25, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- July 25, 2014
- Product Type
- Biologics
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ID · e8f4fde6-d117-4cbb-a236-24bc92d5a95e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 888838
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
5- 21 CFR 1271.50(b)(1)Donor screening standards
- 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)Testing, screening, donor eligibility procedures
- 21 CFR 1271.50(a)Responsible person to determine, document
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Other FDA inspections of Center for Advanced Reproductive Endocrinology
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 13, 2018 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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