Safecor Health, LLC – FDA 483, Oct 19, 2017

Safecor Health, LLC, a drug manufacturer and repacker in Woburn, MA, received a Form 483 with seven observations during an inspection from October 4-19, 2017. The observations primarily highlight significant deficiencies in the firm's Quality Unit, including failures in change control, CAPA management, vendor qualification, process validation, environmental monitoring justification, annual product reviews, and complaint handling procedures. These issues indicate a systemic lack of adherence to established quality control processes, leading to product recalls and potential risks to product quality.