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# FDA Orders GREFI to Stop Making Cell/Tissue Products
- URL: https://www.fdaweb.com/fda-orders-grefi-to-stop-making-cell-tissue-products/
- Published: 2019-12-02T12:00:00.000Z
- Updated: 2026-09-14T15:54:50.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5145619

FDA has ordered Gynecology, Reproductive Endocrinology and Fertility Institute (GREFI) (San Juan, PR) to immediately stop manufacturing cell/tissue products after an October inspection found significant violations. In an [11/25 letter](https://www.fda.gov/media/133059/download?ref=fdaweb.com) to GREFI, the agency says it does not provide adequate protections against the risks of communicable disease transmission and that its products “pose a danger to health.” The inspection found that a donor eligibility determination is not required for reproductive cells or tissue donated by a sexually intimate partner of the recipient for reproductive use, it says.