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FDA Inspection
•North Hudson IVF Center for Fertility & Gynecology P.C.•July 2, 2024

North Hudson IVF Center for Fertility & Gynecology P.C. – FDA Inspection, Jul 2, 2024

Record Details

This FDA Inspection record concerns North Hudson IVF Center for Fertility & Gynecology P.C., with an inspection on July 2, 2024, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
North Hudson IVF Center for Fertility & Gynecology P.C.
Inspection Date
July 2, 2024
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
Person
  • Amy Kim
View Company Profile

ID · f823b401-fa96-40be-b994-89b1ed5392c3

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1242818
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies

FDA Citations

3
  1. 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
  2. 21 CFR 1271.55(b)(2)Listing and interpretation of CD tests performed
  3. 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of North Hudson IVF Center for Fertility & Gynecology P.C.

6
DateClassificationOfficeProject area
March 3, 2022VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
June 11, 2018NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
July 18, 2016NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
April 3, 2014VAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
October 12, 2011NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
View all 6 other inspections on the company page
Other documents for North Hudson IVF Center for Fertility & Gynecology P.C.
  • FDA Inspection 1163522 - 2022-03-03
  • FDA Inspection 1057127 - 2018-06-11
  • FDA Inspection 977405 - 2016-07-18
  • FDA Inspection 873201 - 2014-04-03
  • FDA Inspection 749629 - 2011-10-12

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