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# FDA Warns Miami University Fertility Center
- URL: https://www.fdaweb.com/fda-warns-miami-university-fertility-center/
- Published: 2019-01-29T12:00:00.000Z
- Updated: 2026-09-15T00:58:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143240

FDA has sent University of Miami Reproductive and Fertility Center a just-posted [Warning Letter ](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm629069.htm?ref=fdaweb.com)citing it for significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products that were documented in a 7/2018 inspection. For example, FDA said the center failed to determine as ineligible several donors who were identified as having a risk factor that would exclude them. Additionally, the center failed to prominently label a cell/tissue product with a “biohazard-legend” if results of any screening or testing performed indicate risk factors for, or clinical evidence of, communicable disease agents or diseases.