FDA 483 - Repro Lab, Inc. - November 19, 2024

Repro Lab, Inc. in New York was inspected, revealing two significant issues related to donor eligibility and product release. The firm failed to properly screen repeat semen donors for changes in medical history and lacked a standard operating procedure for releasing HCT/Ps from donors reactive for cytomegalovirus. These findings indicate deficiencies in donor eligibility determination and product release controls.