Mississippi’s Unique Instruments racked up a nine-item Form 483 for numerous quality system failures observed at its Bridgeport facility during an October 2017 inspection.

The sterile packaging process was not properly validated for the company’s Paradigm Spine Coflex Interlaminar devices. For example, during the installation qualification conducted in 2015, not all preventive maintenance requirements were completed. Inspectors noted that during the operational qualification the temperature range was limited, and the firm was unable to provide objective evidence that packages were sealed at the parameter settings defined in the protocol.

The firm failed to establish procedures for monitoring and controlling process parameters for a validated process, procedures to control environmental conditions and corrective and preventive actions.