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

Source: https://www.globalkeysolutions.net/records/483/ivfart-laboratoriesjhh-at-green-spring-station/b62349d0-b57c-4bd3-a31b-9a2325b4d89d

> 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: Baltimore District Office
- Summary: An FDA inspection of Johns Hopkins Fertility Center in Lutherville, MD, a reproductive human tissue establishment, revealed significant deficiencies in donor screening and record-keeping practices. The firm failed to adequately screen oocyte donors for communicable disease risk factors and did not include the establishment's address in the summary of records for HCT/Ps donor eligibility determinations. These issues indicate a failure to ensure the safety and proper documentation of human tissue products.

## Related Documents

- [483 - 2022-10-24](https://www.globalkeysolutions.net/records/483/ivfart-laboratoriesjhh-at-green-spring-station/6a49c185-9449-472c-8b46-458528e7b289)

## Related Officers

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

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

Office: https://www.globalkeysolutions.net/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa