Catalent Maryland IncMarch 10, 2023

FDA 483 - Catalent Maryland Inc - March 10, 2023

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Record Details

An FDA inspection of Catalent Maryland, Inc. in Hanover, MD, a drug substance manufacturer, revealed two observations related to significant failures in the firm's Quality Unit. The Quality Unit failed to ensure the integrity of the Quality Management system by not properly managing change controls and also failed to address issues impacting product quality by not following deviation procedures.

Company: Catalent Maryland Inc
Inspection Date: March 10, 2023
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)

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ID · 0550756e-4e9b-4c8e-9d9d-ff1444350806