Polcz Fertility Lab, LLCJune 27, 2022

FDA 483 - Polcz Fertility Lab, LLC - June 27, 2022

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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.

Company: Polcz Fertility Lab, LLC
Inspection Date: June 27, 2022
Product Type: Biologics
Office: Office of Medical Device and Radiological Health Division II
Person: Ivan E. Reyes

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ID · 44fd45c9-42a6-494e-bcea-e01745bcf0cf