Cell and Tissue Deviations at Palm Beach Fertility Center

A 5/31-6/6/22 FDA inspection at the Palm Beach Fertility Center operated by Dr. Mark Denker in Boca Raton, FL, documented significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products. A just-released 11/17/22 Warning Letter says specific deviations were:

• failing to determine as ineligible a donor who is identified as having a risk factor for, or clinical evidence of, any of the relevant communicable agents or diseases for which screening is required;
• failing to screen a donor of reproductive cells or tissue by reviewing the donor’s relevant medical records for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases;
• failing to maintain documentation of the donor eligibility determination, including the name of the responsible person who made the determination and the date of the determination;
• failure of the summary of records to contain a listing and interpretation of the result of all communicable disease tests performed;
• failing to include in the summary of records a statement noting the reason(s) for the determination of ineligibility in the case of human cells, tissues, and cellular- and tissue-based products (HCT/P) from a donor who is ineligible based on screening and released under regulations;
• failing to establish and maintain procedures for all steps performed in testing, screening, and determining donor eligibility, and complying with all other donor eligibility requirements; and
• failing to establish and maintain a standard operating procedure governing the release of an HCT/P from a donor whose specimen tests reactive for evidence of infection due to cytomegalovirus.

The letter says the center’s response to the form FDA-483 issued at the end of the inspection was inadequate to address the agency’s concerns. It also noted that a 5/10-5/24/18 inspection of the facility resulted in an 11/16/2018 Notice of Violation. So far, it says, FDA has received no response to the untitled letter. Despite a 2018 commitment to make several changes in donor records, FDA says, the 2022 inspection documented many of the same violations, indicating that the center’s corrective actions either were not implemented or were not effective to prevent the recurrence of the previously identified violations. “The agency continues to have serious concerns about your establishment’s ability to maintain compliance” with regulations, FDA says.

Denker was told to respond with a list of specific steps he has taken or plans to take to correct the noted violations and prevent their recurrence, with documentation of the corrections and a schedule for completing the work.