Catalent Argentina Site Passes FDA Inspection

Catalent Pharma Solutions‘ pharmaceutical softgel facility in Buenos Aires, Argentina has successfully completed its first FDA general cGMP audit and pre-approval inspection, with no reported observations on FDA Form 483.

Catalent has been operating in Argentina since 1953 serving local and regional pharmaceutical and consumer health markets, and is completing a substantial expansion of the facility designed to meet FDA and other global regulatory standards. Catalent now has 20 sites approved to produce products registered with the FDA, with two site approvals coming in the last 12 months. In Fiscal 2009 alone, Catalent underwent 10 pre-approval and other inspections by the FDA, along with hundreds of other audits from regulatory authorities and customers, according to a company statement.

“As we celebrate the 75th anniversary of our softgel business, I am very pleased to have reached this important milestone for our global network. This brings our customers an important new supply chain option which further expands Catalent’s global sourcing flexibility. We welcome the opportunity for our experienced team in Buenos Aires to serve new customers, and to build upon their long history of operational performance, quality and compliance,” said Thomas Stuart, the group president of Catalent’s Oral Technologies segment.