FDA Inspection
Batzofin Fertility Services d.b.a. New York Fertility ServicesFDA Inspection 1087800 - Batzofin Fertility Services d.b.a. New York Fertility Services - April 29, 2019
Record Details
This FDA Inspection record concerns Batzofin Fertility Services d.b.a. New York Fertility Services, with an inspection on April 29, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- April 29, 2019
- Product Type
- Biologics
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ID · 255ec4ec-87d5-43cc-8a3a-c868d1f3ef42
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1087800
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 1271.50(b)(1)Donor screening standards
- 21 CFR 1271.80(b)Specimen collections not timely
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Batzofin Fertility Services d.b.a. New York Fertility Services
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 16, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 6, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 10, 2013 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 5, 2011 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Batzofin Fertility Services d.b.a. New York Fertility Services
- FDA Inspection 1003671 - 2017-02-16
- FDA Inspection 925090 - 2015-05-06
- FDA Inspection 830634 - 2013-05-10
- FDA Inspection 724607 - 2011-05-05
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