FDA Inspection
The New York Fertility CenterThe New York Fertility Center – FDA Inspection, Sep 18, 2024
Record Details
This FDA Inspection record concerns The New York Fertility Center, with an inspection on September 18, 2024, issued by the New York District Office, covering biologics.
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ID · bba76c7d-1432-40b4-bf96-c2ab9a721aae
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1249541
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 1271.55(d)(2)Accurate, indelible, legible
- 21 CFR 1271.50(b)(2)Donor testing not negative for CD agents
- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.47(a)Procedures for all other requirements
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Other FDA inspections of The New York Fertility Center
7| Date | Classification | Office | Project area |
|---|---|---|---|
| September 23, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| June 15, 2021 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 27, 2019 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 7, 2016 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 30, 2014 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for The New York Fertility Center
- FDA Inspection 1180091 - 2022-09-23
- FDA Inspection 1144125 - 2021-06-15
- FDA Inspection 1080616 - 2019-02-27
- FDA Inspection 993628 - 2016-12-07
- FDA Inspection 900346 - 2014-10-30
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