483
Repro Lab, Inc.Repro Lab, Inc. – FDA 483, Nov 19, 2024
Record Details
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.
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- New York District Office
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ID · b44f205b-cb35-4b0e-a1e0-6f2bf37d5dfd
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