FDA 483 - General Medical Company - July 23, 2019

The FDA inspected General Medical Company, a medical device manufacturer in Jacksonville, FL, and identified seven significant quality system deficiencies. These included inadequate procedures for Medical Device Reporting (MDR), corrective and preventive actions (CAPA), and process validation. The firm also failed to maintain proper records for device history, acceptance activities, and service reports, with many issues being repeat observations from a previous inspection and cited in a Warning Letter.