FDA Inspection
The Center For Human Reproduction d.b.a. American Infertility of New York, P.C.The Center For Human Reproduction d.b.a. American Infertility of New York, P.C. – FDA Inspection, Apr 30, 2010
Record Details
This FDA Inspection record concerns The Center For Human Reproduction d.b.a. American Infertility of New York, P.C., with an inspection on April 30, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- April 30, 2010
- Product Type
- Biologics
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ID · b42bf11c-8db9-4224-b5fe-3676d1da0319
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 660564
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
5- 21 CFR 1271.55(d)(2)Accurate, indelible, legible
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.47(a)Procedures for all other requirements
- 21 CFR 1271.47(a)Design of procedures to ensure compliance
- 21 CFR 1271.50(a)Responsible person to determine, document
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Other FDA inspections of The Center For Human Reproduction d.b.a. American Infertility of New York, P.C.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| May 1, 2024 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 11, 2022 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 9, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 3, 2017 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 14, 2015 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for The Center For Human Reproduction d.b.a. American Infertility of New York, P.C.
- FDA Inspection 1237978 - 2024-05-01
- FDA Inspection 1167650 - 2022-04-11
- FDA Inspection 1065664 - 2018-08-09
- FDA Inspection 1009224 - 2017-03-03
- FDA Inspection 909449 - 2015-01-14
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