Penn Pharma’s Tredegar, South Wales facility has successfully completed a routine FDA inspection. The inspection covered compliance with cGMP and included two PAIs (Pre-Approval Inspections), both of which were also successful. 
 
The inspection reviewed selected systems, processes and procedures related to the development, manufacture and packing of products for the U.S. market, with no Form 483 observations recorded. 
 
Richard Yarwood, chief executive officer, 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.”