Alphatec Spine, Inc. – FDA 483, Feb 11, 2010

Alphatec Spine, Inc., a medical device manufacturer in Carlsbad, CA, was cited for multiple quality system deficiencies during an FDA inspection. Key issues included inadequate medical device reporting (MDR) practices, incomplete design output identification, insufficient process validation for sterilization, and failures in complaint handling and corrective/preventive actions. The inspection revealed a pattern of non-compliance across several critical areas of device manufacturing and quality control.