Catalent has reported the successful completion of the first FDA general cGMP audit and pre-approval inspection of its Buenos Aires, Argentina pharmaceutical softgel facility, with no reported observations on FDA Form 483.
Catalent now has 20 sites approved to produce products registered with the FDA, with two new site approvals coming in the last 12 months. In addition, many of Catalent’s facilities are registered with other regulatory authorities, including the EMEA, and some facilities have multiple regulatory approvals.
The company said that in FY2009, it underwent 10 pre-approval and other inspections by the FDA, along with hundreds of other audits from regulatory authorities and customers.
Thomas Stuart, group president of oral technologies segment at Catalent, said: “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.