FDA WARNING_LETTER - Repromed Fertility Center - April 02, 2014

On March 27-April 2, 2014, the FDA inspected Repromed Fertility Center, identifying significant deviations from 21 CFR Part 1271 for human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Violations include: 1. Failure to collect donor specimens for communicable disease testing within the required timeframe (seven days before or after recovery). For example, a semen donor's specimen was collected on January 30, 2013, but semen was recovered on February 28, 2013. 2. Failure to screen donors by reviewing relevant medical records for communicable disease risk factors and clinical evidence. This included not conducting physical assessments or completing Donor Medical History Interview and/or Donor Physical Assessment forms prior to determining donor eligibility for multiple anonymous and directed oocyte donors. 3. Failure to determine donor eligibility based on complete donor screening and testing results. The firm determined donor eligibility prior to receiving donor testing results in several instances. For example, an anonymous oocyte donor was deemed eligible on August 5, 2013, but test results were reported on August 7, 2013.

The FDA acknowledged the firm's April 14, 2014, response but deemed it inadequate. The response only addressed prospective changes and failed to address screening and testing for all previous donors or the increased risk