FDA 483 - ESTABLISHMENT LABS SA - July 26, 2024

ESTABLISHMENT LABS SA, a medical device manufacturer in Alajuela, Costa Rica, was cited for three significant issues during an FDA inspection. Observations included late reporting of Medical Device Reports for the Motiva Flora Tissue Expander, inadequate training documentation for a validated manufacturing process, and a lack of auditor independence in their internal quality audit program. These findings indicate deficiencies in quality system controls and regulatory reporting.