# FDA 483 - Brown Fertility Associates, PA - September 25, 2024

Source: https://www.keypedia.com/records/483/brown-fertility-associates-pa/222a551b-0bd2-47a9-9a76-f792887f17c8

> FDA 483 for Brown Fertility Associates, PA on September 25, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Brown Fertility Associates, PA
- Inspection Date: 2024-09-25
- Product Type: biologics
- Office Name: Florida District Office
- Summary: An FDA inspection of Brown Fertility Associates, PA in Jacksonville, FL, a human reproductive tissue/fertility clinic, revealed two significant observations. The firm failed to prominently label HCT/Ps with appropriate warning statements when donor eligibility determinations were not required, specifically for donations later used with gestational carriers. Additionally, the summary of records for HCT/Ps did not include a complete listing and interpretation of all communicable disease test results performed on donors.

## Related Officers

- [Investigator at U.S.FDA](https://www.keypedia.com/people/barbara-t-carmichael/4c451805-e327-450d-b2e5-48a40f6232fe)

Company: https://www.keypedia.com/companies/brown-fertility-associates-pa/fec2acbd-3474-4882-b71c-10df0c102f16

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9