FDA 483 - Hologic Surgical Products Costa Rica, S.R.L. - September 09, 2024

An FDA inspection of Hologic Surgical Products Costa Rica SRL in El Coyol Alajuela revealed two significant observations. The firm failed to ensure Device History Records accurately reflect manufacturing processes and did not adequately establish procedures for receiving, reviewing, and evaluating complaints, including trending and investigation. These issues indicate deficiencies in the firm's quality system for medical device manufacturing.