FDA Inspection
Reproductive Medicine Associates of New York, LLPReproductive Medicine Associates of New York, LLP – FDA Inspection, Apr 13, 2018
Record Details
This FDA Inspection record concerns Reproductive Medicine Associates of New York, LLP, with an inspection on April 13, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- April 13, 2018
- Product Type
- Biologics
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ID · 4bb566b5-aebb-4fb7-8548-efaa1a36665b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1048026
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 1271.85(b)(2)Cytomegalovirus (CMV)
- 21 CFR 1271.47(a)Procedures for all other requirements
- 21 CFR 1271.55(b)(2)Listing and interpretation of CD tests performed
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Other FDA inspections of Reproductive Medicine Associates of New York, LLP
6| Date | Classification | Office | Project area |
|---|---|---|---|
| January 31, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 22, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| February 10, 2016 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 18, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 16, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Reproductive Medicine Associates of New York, LLP
- FDA Inspection 1228769 - 2024-01-31
- FDA Inspection 1175738 - 2022-07-22
- FDA Inspection 958827 - 2016-02-10
- FDA Inspection 859413 - 2013-12-18
- FDA Inspection 794516 - 2012-08-16
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