FDA 483 - Pantheon Spinal LLC - January 25, 2018

Pantheon Spinal LLC, a specification developer in Austin, TX, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included inadequate design validation for spinal implants, lack of established procedures for design changes, and deficiencies in corrective and preventive action (CAPA) and complaint handling procedures. The firm failed to ensure device conformity through validation and properly document and manage quality issues.