FDA 483 - General Medical Company - July 23, 2019
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 841575f7-3df0-459d-be5d-50ff788b3692