FDA 483 - Michael A. Werner MD PC/dba M.A.Z.E Laboratories - August 19, 2022

Michael A. Werner MD PC/dba M.A.Z.E Laboratories in New York, NY, received a Form 483 with one observation concerning inadequate donor screening practices. The firm failed to properly screen directed semen donors for various communicable disease agents, including HTLV I/II, sepsis, and ZIKV, using outdated or insufficient medical history questionnaires. This resulted in the release of vials from inventory for donors whose eligibility was not fully determined according to regulations.