FDA 483 - Perryman Company - October 10, 2019

Perryman Company, a manufacturer of implantable medical devices in Houston, PA, was cited for two observations during an FDA inspection. The firm failed to adequately review and investigate customer rejection reports as complaints, and their procedures for corrective and preventive actions were not adequately established. These findings indicate deficiencies in the company's quality system regarding complaint handling and CAPA processes.