FDA 483 - Retro & R-Med Molding, LLC - July 22, 2021

Retro & R-Med Molding, LLC in Constantine, MI, a medical device manufacturer, received a Form 483 with nine observations following an FDA inspection. The inspection revealed a comprehensive lack of established written procedures across all critical quality system elements. This indicates significant deficiencies in the firm's quality management system, impacting areas from general quality system procedures to specific controls for manufacturing, equipment, and records.