mark s. denker, m.d., pa – FDA Warning Letter, Jun 6, 2022

The FDA inspected Mark S. Denker, M.D., PA dba Palm Beach Fertility Center, from May 31 to June 6, 2022, and found significant deviations from 21 CFR Part 1271 for human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Key violations include: 1. **Failure to determine donor ineligibility:** Donors with risk factors (e.g., sex with another man, living in Europe) were deemed eligible. 2. **Inadequate donor screening:** The Donor Medical History Interview Form failed to screen for syphilis, West Nile Virus, blood transfusions in France, and specific military service in Europe. 3. **Missing documentation:** Donor eligibility determinations lacked the name of the responsible person and date. 4. **Inaccurate records:** Summary of records incorrectly stated CMV test results. 5. **Incomplete ineligibility reasons:** Reasons for donor ineligibility were not accurately or completely documented in the summary of records. 6. **Deficient procedures:** Procedures for donor testing, screening, and eligibility determination did not include required tests (HIV NAT, HBV NAT, HCV NAT, West Nile Virus) and contained incorrect statements regarding donor eligibility and labeling for positive test results. 7. **Lack of CMV procedure:** No standard operating procedure for communicating positive CMV test results to physicians.

The FDA noted that