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483
•Society Hill Reproductive Medicine•April 11, 2024

Society Hill Reproductive Medicine – FDA 483, Apr 11, 2024

Record Details

Society Hill Reproductive Medicine in Philadelphia was inspected regarding its reproductive HCT/P operations. The inspection revealed that HCT/P donors were not properly determined eligible due to the use of an outdated Zika Virus risk assessment list, which omitted relevant countries. This indicates a failure in donor screening procedures and non-compliance with the firm's standard operating procedure.

Company
Society Hill Reproductive Medicine
Inspection date
April 11, 2024
Product type
biologics
Office
Philadelphia District Office
Person
  • Emily A. Walters (issuing_officer)
View Company Profile

ID · 7a910999-150b-458e-9f76-b5067812bd92

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