FDA 483 - ARTAFLEX BUFFALO INC - July 09, 2026
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · a9290441-99e2-4aad-8f84-5c4b979a1381