FDA 483 - Red Medical Solutions, Inc. - March 22, 2023

An FDA inspection of Red Medical Solutions, Inc., a medical device importer and exporter in Patchogue, NY, revealed significant deficiencies in their quality system. The firm failed to establish procedures for receiving, reviewing, and evaluating customer complaints. Additionally, the company lacked established procedures for corrective and preventive actions, particularly concerning investigations into non-conforming devices.