In a rare occurrence, 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. Paul Thomas, Technical Director at Penn, explains; It is somewhat unique 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. " "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." The FDA is the federal science-based law enforcement agency mandated to protect public health. Penn Pharmaceutical Services Ltd is a leading provider of outsourced pharmaceutical development services to the international healthcare industry. The company’s core business expertise includes a fully comprehensive product development service, which consists of formulation and analytical development, clinical trial manufacturing, packaging and supply management and extensive contract manufacturing. Penn also offers CMC Consultancy and Qualified Person (QP) Services.