November 2, 2016- Clinical Supplies Management is pleased to announce the completion of a successful inspection of their Malvern, Pennsylvania facility by the US Food and Drug Administration (FDA) from October 24, 2016 to October 26, 2016.
The FDA performed the three-day general GMP inspection of the facility which included primary and secondary packaging, labeling, warehousing, cold chain storage, and distribution operations as well as an assessment of CSM's Quality Management System. The inspection was a great success with no recommendations or 483's issued.
Commenting on the inspection, Angela Calkins Humrich, Director of Quality and Regulatory Affairs, said, "We are very happy with the results of our first inspection of CSM's new center of excellence for primary packaging. It is an affirmation to the continued dedication and commitment of our employees and the adherence to quality as one of our most important core values."
CSM provides clinical packaging and labeling, storage, distribution, returns and reconciliation, and clinical supplies consulting services with quality-driven processes to enhance biotechnology and pharmaceutical clinical trials worldwide. The company continues to evolve with its blend of unique and traditional clinical trial services that improve efficiency and accuracy. CSM is the innovator of On-Demand Packaging and Labeling services, an industry breakthrough in which clinical supplies are prepared specifically for, and immediately prior to, each shipment. In addition, CSM continues to lead the development of Direct-to-Patient shipping for clinical trials, helping sponsor companies develop new ways to reach their patients. CSM's other core services include: cold chain logistics, controlled drug services, clinical label printing, and global distribution. For more information, visit www.csmondemand.com.