FDA 483 - Trinity Orthopedics, LLC - August 27, 2021

Trinity Orthopedics, LLC, a medical device manufacturer in San Diego, CA, was cited for significant deficiencies in its quality system during an FDA inspection. The inspection revealed failures in complaint handling, corrective and preventive actions, design input documentation, and risk analysis for its medical devices. These issues indicate a lack of robust controls to ensure device quality and patient safety.