Alphatec Spine, Inc. – FDA 483, Dec 13, 2010

Alphatec Spine, Inc. in Carlsbad, CA, a medical device manufacturer, received an FDA Form 483 citing significant quality system deficiencies. These included inadequate validation of sterilization processes, uncontrolled production leading to device specification non-conformance, and failures in corrective and preventive action procedures. The inspection also highlighted lapses in MDR reporting, management review frequency, equipment calibration, and personnel training documentation.