FDA 483 - ARCHFORM INC - July 28, 2025

ARCHFORM INC, a manufacturer of Class 2 ArchForm Aligners in Santa Clara, CA, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately establish and follow procedures for corrective and preventive actions, complaint handling, and the control of non-conforming products. These issues include a lack of investigation for numerous non-conformances and customer complaints, indicating a systemic breakdown in quality management.