ARTAFLEX BUFFALO INC – FDA 483, Jul 9, 2026

ARTAFLEX BUFFALO INC, a medical device contract manufacturer in Buffalo, NY, received three observations during an FDA inspection. The observations highlight significant deficiencies in the firm's quality system, specifically regarding inadequate documentation and implementation of production controls for labeling and packaging, procedures for nonconforming product, and risk management processes. These issues indicate a lack of robust controls over critical manufacturing and quality assurance activities.