FDA 483 - GRAMERCY EXTREMITY ORTHOPEDICS - October 06, 2022

During an inspection, GRAMERCY EXTREMITY ORTHOPEDICS, a medical device manufacturer in Richardson, TX, was cited for inadequate procedures for receiving, reviewing, and evaluating complaints. The firm failed to consistently gather additional product information for failure analysis and did not establish proper procedures to determine if complaints required Medical Device Reporting to the FDA, indicating significant quality system deficiencies.