FDA Inspection
Hudson Valley Fertility, PLLCHudson Valley Fertility, PLLC – FDA Inspection, Jun 6, 2018
Record Details
This FDA Inspection record concerns Hudson Valley Fertility, PLLC, with an inspection on June 6, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · a8eb1ab6-e60e-4f3b-baf1-81de55bc1968
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1054546
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
3- 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)Testing, screening, donor eligibility procedures
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Other FDA inspections of Hudson Valley Fertility, PLLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 31, 2024 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 20, 2022 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 19, 2016 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 18, 2013 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 2, 2010 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Hudson Valley Fertility, PLLC
- FDA Inspection 1228929 - 2024-01-31
- FDA Inspection 1170360 - 2022-05-20
- FDA Inspection 985373 - 2016-08-19
- FDA Inspection 840036 - 2013-07-18
- FDA Inspection 700064 - 2010-12-02
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