Successful inspection by FDA of Penn Pharma’s development and production facility

Penn Pharma announced today that its Tredegar, South Wales facility has successfully completed a routine FDA inspection.  The inspection which covered compliance with cGMP (current Good Manufacturing Practice) also included two PAIs (Pre-Approval Inspections), both of which were also successful. 

 

The inspection, undertaken during August, reviewed selected systems, processes and procedures related to the development, manufacturing and packing of products for the US market and no Form 483 observations were recorded. 

 

Commenting on the inspection, Richard Yarwood, CEO said: “We are extremely pleased with this successful inspection which confirms Penn’s commitment to meeting the highest quality standards.  We will continue to invest in improving our quality systems to provide even greater assurances to our customers.”