483
Catalent Maryland IncCatalent Maryland Inc – FDA 483, Mar 10, 2023
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.
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ID · 0550756e-4e9b-4c8e-9d9d-ff1444350806
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