M.A.Z.E. Laboratories – FDA 483, Dec 17, 2021

M.A.Z.E. Laboratories in Purchase, NY, was cited for deficiencies in its human reproductive tissue operations, specifically concerning donor screening and record-keeping. The inspection revealed incomplete screening for Zika virus in semen donors and a failure to include required statements about CLIA certification for communicable disease testing in HCT/P records. These issues indicate a lack of adequate controls to ensure donor eligibility and product safety.