Scott Health Services LLCJuly 22, 2019

FDA 483 - Scott Health Services LLC - July 22, 2019

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Record Details

An FDA inspection of Scott Health Services, LLC in New Albany, Indiana, revealed a significant deficiency in their clinical trial practices. The firm failed to retain samples of investigational drug product and reference standards used in a bioequivalence study, specifically from a shipment received in July 2018. This lapse prevents the FDA from requesting and analyzing these critical samples as required for regulatory compliance.

Company: Scott Health Services LLC
Inspection Date: July 22, 2019
Product Type: Drugs
Office: Division of Pharmaceutical Quality Operations III
Person: Karen M. Cooper (investigator)

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ID · 882a1de9-e3b0-4881-a068-9a5bd75bf930