FDA 483 - Realized Mfg LLC - August 27, 2025

Realized Mfg LLC, a medical device manufacturer in Medina, OH, was inspected and cited for significant quality system deficiencies. Observations included inadequate procedures for corrective and preventative actions, insufficient process validation for manufacturing and cleaning, and a failure to ensure all monitoring equipment is routinely calibrated and maintained. These issues indicate a lack of robust quality control over critical manufacturing processes and device quality.