# FDA 483 - IVF/ART Laboratories/JHH at Green Spring Station - October 24, 2022

Source: https://www.keypedia.com/records/483/ivfart-laboratoriesjhh-at-green-spring-station/6a49c185-9449-472c-8b46-458528e7b289

> FDA 483 for IVF/ART Laboratories/JHH at Green Spring Station on October 24, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: IVF/ART Laboratories/JHH at Green Spring Station
- Inspection Date: 2022-10-24
- Product Type: biologics
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of IVF/ART Laboratories/JHH at Green Spring Station in Lutherville, MD, identified two observations related to donor screening and eligibility for anonymous oocyte donors. The firm failed to adequately screen donors for communicable disease risk factors, specifically Zika virus, and determined donor eligibility before infectious disease testing results were available.

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## Related Officers

- [issuing_officer](https://www.keypedia.com/people/brandon-l-mariner/c1ff0e66-552d-466a-9b49-a083d0211c94)

Company: https://www.keypedia.com/companies/ivfart-laboratoriesjhh-at-green-spring-station/e304e0b8-1848-49f7-9a86-158b4627de3c

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64