Saris and Things, Inc. – FDA 483, Jun 10, 2026

Saris and Things, Inc. in Plainfield, IL, a repackager/relabler of medical devices, received an FDA Form 483 for significant deficiencies in its quality management system. The firm failed to document and maintain critical aspects of its QMS, including risk management, software validation, supplier control, medical device files, and production control. These findings indicate a fundamental lack of adherence to applicable regulatory requirements for medical device operations.