FDA 483 - Boiron - November 29, 2024

Boiron, a homeopathic drug manufacturer in Montrevault, France, was cited for significant deficiencies in its microbiological testing methods, environmental monitoring investigations, and cleanroom cleaning and disinfection processes. The inspection revealed inadequate validation of test methods for media, drug solutions, and finished products, as well as a failure to properly investigate environmental monitoring excursions involving pathogens. Additionally, the firm lacked disinfectant efficacy studies and qualification of its cleanroom decontamination process, indicating a high severity of non-compliance in aseptic processing.