FDA 483 - Exercore, LLC - September 02, 2021

Exercore, LLC, a manufacturer in Shakopee, MN, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included inadequate procedures for incoming product acceptance and quality audits, insufficient documentation for complaint investigations, and a non-compliant and inaccessible design history file with untranslated foreign language content. These issues indicate a lack of robust quality management practices.