483
Denker, Mark S, MD PADenker, Mark S, MD PA – FDA 483, Jun 6, 2022
Record Details
An FDA inspection of Mark S. Denker, M.D., PA, a reproductive tissue establishment in Boca Raton, FL, revealed significant deficiencies in donor screening, eligibility determination, record-keeping, and labeling practices for HCT/Ps. The firm failed to adequately screen donors for communicable disease risk factors, maintain proper documentation, and correctly interpret test results. Several observations were repeats from a previous inspection, indicating persistent issues.
View Company Profile
ID · d707f56a-24f2-4475-bf9d-d5350e692fff
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.