Society Hill Reproductive MedicineApril 11, 2024

FDA 483 - Society Hill Reproductive Medicine - April 11, 2024

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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 The inspection revealed that HCT/P donors were not properly determined eligible due to the use of an outdated Zika Virus risk assessment list, which omitted relevant countries.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)

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