FDA completes inspection of Catalent Pharma's manufacturing facility in Germany

Catalent Pharma Solutions announces that its integrated dose form development, manufacturing and packaging facility in Schorndorf, Germany, has successfully completed an FDA inspection. This inspection, triggered by pre-approval inspection requirements for two separate products, resulted in three minor observations on FDA Form 483. The Schorndorf facility currently produces products approved by other regulators including those in Germany, Brazil and Taiwan.

Catalent’s Schorndorf business, originally founded in 1973, 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 integrated product development and commercial supply chain solutions for products in these dosage forms.

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 United States.”