# FDA 483 - IVF/ART Laboratories/JHH at Green Spring Station - August 14, 2025

Source: https://www.keypedia.com/records/483/ivfart-laboratoriesjhh-at-green-spring-station/e0cc7e65-c35d-45d9-9bc8-871c3ff5fc38

> FDA 483 for IVF/ART Laboratories/JHH at Green Spring Station on August 14, 2025. 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: 2025-08-14
- Product Type: biologics
- Office Name: Office of Regulatory Affairs
- Summary: John Hopkins Fertility Center in Lutherville, MD, received a Form 483 with two observations during an inspection of its reproductive human tissue establishment. The firm failed to adequately screen oocyte donors for communicable disease risk factors due to a deficient medical history questionnaire. Additionally, the summary of records for HCT/Ps did not include the address of the establishment that made the donor-eligibility determination.

## Related Documents

- [483 - 2022-10-24](https://www.keypedia.com/records/483/ivfart-laboratoriesjhh-at-green-spring-station/6a49c185-9449-472c-8b46-458528e7b289)
- [483 - 2025-08-14](https://www.keypedia.com/records/483/ivfart-laboratoriesjhh-at-green-spring-station/b62349d0-b57c-4bd3-a31b-9a2325b4d89d)

## Related Officers

- [La-tasha M. Gunter](https://www.keypedia.com/people/la-tasha-m-gunter/db9cd9cf-db0a-4c31-9f7c-24760750f34d)

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