FDA 483 - BE Pharmaceuticals Private Ltd. - July 07, 2023

BE Pharmaceuticals Private Ltd. in Tehsil Paonta Sahib, India, was inspected and cited for significant deficiencies across its laboratory, quality, materials, and production systems. Observations include inadequate sterility testing media qualification, deficient method verification, poor OOS investigation practices, unreliable component testing, and failures in aseptic processing area cleaning and personnel hygiene. These issues indicate a lack of robust quality control and assurance for sterile drug product manufacturing.