Boiron Inc. – FDA 483, Jun 26, 2026

During an inspection, Boiron Inc. in Newtown Square, PA, a repacker, was cited for two significant deficiencies related to their quality systems. The firm failed to document employee training for new warehouse operations and did not initiate a required change control for the relocation of its warehousing activities. These observations indicate a lack of adherence to current good manufacturing practice regulations and internal procedures.