Randy Morris MD SCJune 14, 2023

FDA 483 - Randy Morris MD SC - June 14, 2023

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Record Details

Randy Morris MD SC, a human tissue reproductive establishment in Naperville, IL, was cited by the FDA for failing to adequately screen donors. The inspection revealed that donors were not screened for risk factors and clinical evidence of communicable disease agents, specifically regarding West Nile Virus. This indicates a significant deficiency in ensuring donor eligibility and product safety.

Company: Randy Morris MD SC
Inspection Date: June 14, 2023
Product Type: Biologics
Office: Chicago District Office
Person: Paul M. Chefor (Investigator)

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ID · 91e33f1d-d61c-4217-9816-7ddbaff061c7