FDA 483 - Encore, Inc. - February 20, 2020

Encore, Inc., a medical device specification developer in Sarasota, FL, was inspected by the FDA, revealing significant deficiencies in its quality system. The inspection cited inadequate procedures for controlling nonconforming product, managing purchased services, handling complaints, and documenting design changes. These issues indicate a lack of robust controls over critical aspects of medical device development and manufacturing.