Steribite, LLC – FDA 483, Apr 8, 2026

Steribite, LLC, a medical device manufacturer in Wooster, OH, received 12 observations during an FDA inspection, highlighting significant deficiencies across its quality management system. The firm failed to adequately document design and development procedures, validate critical manufacturing processes, control nonconforming products, and manage outsourced activities. These issues indicate a broad lack of adherence to regulatory requirements for medical device production.