FDA 483 - Bell-More Labs, Inc. - April 03, 2024

Bell-More Labs, Inc., a sterile drug manufacturer in Hampstead, MD, was cited for significant deficiencies in its aseptic processing and quality control systems. The inspection revealed widespread issues including inadequate sterility assurance for drug product stoppers, unvalidated sterilization processes, ineffective investigations into microbial contamination and particulate excursions, and critical failures in environmental monitoring and facility maintenance. These conditions raise serious concerns about the sterility and quality of both human and veterinary drug products manufactured at the facility.