FDA Inspection
Center for Advanced Reproductive EndocrinologyCenter for Advanced Reproductive Endocrinology – FDA Inspection, Nov 13, 2018
Record Details
This FDA Inspection record concerns Center for Advanced Reproductive Endocrinology, with an inspection on November 13, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- November 13, 2018
- Product Type
- Biologics
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ID · cf8d4260-921d-45b2-81b5-6c583cab9384
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1071477
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
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Other FDA inspections of Center for Advanced Reproductive Endocrinology
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 25, 2014 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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