FDA 483 - Howmedica Osteonics Corp. - December 01, 2023

Howmedica Osteonics Corp. in Mahwah, NJ, was inspected by the FDA from November 15 to December 1, 2023. The inspection revealed deficiencies in the firm's training procedures, specifically noting that required training for sales representatives was not adequately established or completed. This indicates a lapse in the firm's quality system regarding personnel training.