FDA 483 - F. M. Howell & Company Inc. - October 10, 2025

F. M. Howell & Company in Elmira, NY, a repacker/relabeler, was cited for deficiencies related to its quality control unit and change management process. The firm's procedures for process change control were found to be inadequate, specifically failing to address changes in repacking processes and the installation of new GMP equipment. This indicates a significant lapse in ensuring the quality and control of their packaged products.