FDA 483 - Retrofix Screws LLC - July 01, 2022

An FDA inspection of Retrofix Screws LLC in Salisbury, NC, revealed significant deficiencies in their quality system for orthopedic screws. The firm lacked adequate procedures and records for design validation, design plans, design output, process validation, nonconforming product control, and incoming product acceptance. These issues indicate a systemic failure to establish and follow essential quality system requirements for medical device manufacturing.