FDA 483 - Boiron Inc. - October 25, 2021

Boiron Inc., a homeopathic drug manufacturer in Newtown Square, PA, was cited for significant deficiencies in quality control and testing during an FDA inspection. Observations included failure to verify supplier component reliability, lack of stability studies for drug products, inadequate quality unit oversight, absence of finished product release testing, and neglected annual inspection of reserve samples. These issues indicate a systemic breakdown in ensuring product quality and compliance with manufacturing standards.