Penn passes two US FDA audits
Penn Pharmaceutical Services, a UK provider of integrated pharmaceutical outsourcing services, has undergone two successful audits by the US FDA in as many weeks.
Penn Pharmaceutical Services, a UK provider of integrated pharmaceutical outsourcing services, has undergone two successful audits by the US FDA in as many weeks.
Unusually, Penn was audited by two separate FDA Centres on consecutive weeks - one by CDER for a capsule product and one by CDRH for a medical device on behalf of BioMimetic Therapeutics.
'It is highly unusual to receive two back-to-back audits from the FDA on consecutive weeks. The audits themselves were the culmination of approximately 18 months of work on each project and, as a result, we were able to support these audits in a manner which enabled the inspector to indicate that an acceptable verdict would be recommended on our activities,' said Paul Thomas, technical director at Penn.
'The preparation process spanned all departments and this success is testament to the hard work shown by all staff, particularly those directly involved in the formulation development, analytical development and manufacturing activities for these projects.'