FDA Inspection
Center For Advanced Reproductive Medicine & FertilityCenter For Advanced Reproductive Medicine & Fertility – FDA Inspection, Oct 27, 2011
Record Details
This FDA Inspection record concerns Center For Advanced Reproductive Medicine & Fertility, with an inspection on October 27, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- October 27, 2011
- Product Type
- Biologics
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ID · 6555480c-7efb-496f-9a3f-df6fdea42765
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 752438
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
5- 21 CFR 1271.80(c)Kits not FDA approved, specifically labeled
- 21 CFR 1271.47(b)Review and approval of procedures
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.85(a)Infection with communicable disease agents
- 21 CFR 1271.47(a)Procedures for all other requirements
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Other FDA inspections of Center For Advanced Reproductive Medicine & Fertility
7| Date | Classification | Office | Project area |
|---|---|---|---|
| July 15, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 14, 2022 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 19, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 3, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 11, 2016 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Center For Advanced Reproductive Medicine & Fertility
- FDA Inspection 1244251 - 2024-07-15
- FDA Inspection 1167958 - 2022-04-14
- FDA Inspection 1096785 - 2019-07-19
- FDA Inspection 1002162 - 2017-03-03
- FDA Inspection 958542 - 2016-02-11
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