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Brecon Successfully Completes First FDA Audit

Enhances global harmonization efforts

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Brecon Pharmaceuticals has successfully completed the first FDA audit of its Hay-on-Wye facility in Wales, UK, which is now compliant with FDA standards. Brecon is now compliant with European, U.S. and ISO 9001:2008 standards and provides a range of customized primary and secondary commercial and IMP packaging solutions of medications and licensed pharmaceuticals.  

Kay O’Hagan, director of Quality Assurance and Regulatory Affairs at Brecon, said, “This is a significant achievement for Brecon. Today, our Commercial and IMP Packaging facilities are now fully compliance to key European and FDA standards which gives us the capabilities to offer our customers a global launch-pad for their products from our Hay-on-Wye facility. Furthermore, this successful completion of the audit also enhances the global harmonization of our Pharmaceutical Packaging solutions offering that we can deliver working alongside sister company Anderson Packaging as part of AndersonBrecon Clinical Services.”

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