The FDA found that Orthopedic Alliance was not in conformity with the “current good manufacturing practice requirements of the Quality System regulation.” The violations include failure to establish and maintain procedures for implementing corrective and preventative actions and failure to establish and maintain procedures for control and distribution of the finished devices.
The investigation also found Orthopedic Alliances’ U2 Total Knee System, SC Total Hip System and SC Ceramic Ball Heads were misbranded because the company did not provide required information about the device.
Spinal Solutions was cited for several violations, including failure to establish quality audits and failure to maintain procedures to control a product that does not conform to specific requirements. The company also did not provide package inserts for their spinal system, which is required.
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