Barnett International Corporation – FDA 483, Jul 30, 2026

An FDA inspection of Barnett International Corporation in Stallings, NC, revealed significant deficiencies in their quality system, specifically regarding record-keeping for Class II medical device packaging. The firm failed to maintain records for process checks and material changes, and lacked written procedures for process validation, design control, or change control. These issues indicate a moderate severity of non-compliance with regulatory requirements for medical device manufacturing.