Limber Prosthetics and Orthotics, Inc – FDA 483, Mar 20, 2026

Limber Prosthetics and Orthotics, Inc. in San Diego, CA, was inspected and cited for significant deficiencies in its quality management system. The inspection revealed failures in software validation for prosthetic limb design and manufacturing, inadequate control over outsourced coating processes, and incorrect Unique Device Identifier (UDI) information submitted to the FDA's GUDID. These issues indicate a lack of robust quality controls for a Class II medical device manufacturer.