483
Polcz Fertility Lab, LLCPolcz Fertility Lab, LLC – FDA 483, Jun 27, 2022
Record Details
An FDA inspection of Polcz Fertility Lab, LLC in Boynton Beach, FL, a reproductive tissue establishment, revealed significant deficiencies in donor screening practices. The firm failed to adequately screen donors for communicable disease risk factors and lacked established written procedures for HCT/P donor screening. These issues indicate a potential risk to public health regarding the safety of donated tissues.
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ID · 44fd45c9-42a6-494e-bcea-e01745bcf0cf
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