FDA 483 - Logic PD, LLC - March 18, 2022

Logic PD, LLC, a device manufacturer in Eden Prairie, MN, was inspected by the FDA from March 8-18, 2022. The inspection revealed significant deficiencies in the firm's quality system, specifically regarding complaint handling and corrective and preventive actions. The firm failed to adequately document and evaluate validated customer complaints and did not follow its own procedures for escalating recurring complaints to CAPA or non-conformance.