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Catalent’s German Facility Successfully Audited

Catalent Pharma Solutions’ dose form development, manufacturing and packaging facility in Schorndorf, Germany, has successfully completed an FDA inspection.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Catalent Pharma Solutions’ dose form development, manufacturing and packaging facility in Schorndorf, Germany, has successfully completed an FDA inspection. The inspection, triggered by pre-approval inspection requirements for two separate products, resulted in three minor observations on FDA Form 483. Sharon Johnson, Catalent’s executive vice president of Quality, said, “The success of this inspection again demonstrates Catalent’s operational performance, depth of regulatory expertise, trac...

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