Main Line Fertility CenterJune 11, 2019

FDA 483 - Main Line Fertility Center - June 11, 2019

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Record Details

An FDA inspection of Main Line Fertility Center in Bryn Mawr, PA, identified a significant deficiency in their donor screening procedures. The facility failed to adequately screen 17 out of 20 anonymous oocyte donors for all relevant Zika Virus risk factors, a designated communicable disease. This lapse indicates a failure to ensure proper screening for communicable disease agents in human tissue for reproductive use.

Company: Main Line Fertility Center
Inspection Date: June 11, 2019
Product Type: Biologics
Office: Philadelphia District Office
Person: Nikisha Rolden

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ID · 02098c6c-adab-4b67-9ff0-6e2996aeb060