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. 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, track record of quality and commitment to excellence. We are pleased to offer our customers added flexibility in their supply chain options for products coming to the U.S.”

Catalent’s Schorndorf business provides formulation and development services, clinical and commercial manufacturing for oral tablet and capsules, powders and other dose forms. The business also provides clinical and commercial packaging, clinical supply chain management services, and product development and commercial supply chain solutions for products in these dosage forms.