FDA 483 - C-Axis PR., Inc. - October 24, 2024

An FDA inspection of C-Axis PR., Inc., a contract manufacturer in Caguas, PR, revealed two significant issues. The firm failed to adequately establish procedures for the acceptance of incoming product, specifically regarding sample size for inspection. Additionally, procedures for training and identifying training needs were not adequately established, as evidenced by a lack of documentation for employee training in 2023.