Catalent Pharma Solutions German facility completes FDA audit

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

This inspection, triggered by pre-approval requirements for two separate products, resulted in three minor observations. The facility currently produces products approved by regulators in Germany, Brazil and Taiwan.

The US company's Schorndorf business, founded in 1973, provides formulation and development services, clinical and commercial manufacturing for oral tablets and capsules, powders and other dose forms. It 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.