FDA 483 - Greer Laboratories, Inc. - November 01, 2022

Greer Laboratories, Inc. in Lenoir, NC, was inspected and cited for significant deficiencies in its quality system for medical devices. Observations included a lack of design validation for medical devices, failure to timely report a recall, and inadequate procedures and documentation for corrective and preventive actions, quality audits, supplier qualification, and management reviews. These issues indicate systemic problems in maintaining a compliant quality management system.