FDA successfully completed inspections of Sifavitor and Labochim
Infa Group is pleased to announce that the US Food and Drug Administration (FDA) successfully completed the inspections of both Italian active pharmaceutical ingredient (API) manufacturing facilities Sifavitor and Labochim.
Both facilities and the quality systems used for the manufacture and release of APIs were subject to a detailed compliance inspection. The FDA inspected the Sifavitor facility from April 27 through April 30, 2015 and found the site to be compliant with the principles and guidelines of Good Manufacturing Practices with no Form 483 observations issued. Labochim was inspected from May 4 through 8, 2015 resulting in two minor observations.
Daniele Cardoso, Chairman of Infa Group, commented: “We are very pleased with the results of this latest FDA inspection, which further strengthens our decades-long track record of outstanding regulatory compliance. We commit significant resources and work diligently to maintain high quality standards and continuously improve quality platforms at all our manufacturing sites”.