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

During an inspection from March 12 to April 3, 2024, the FDA issued a Form 483 to Bell-More Labs, Inc., a sterile drug manufacturer. The observations detailed significant deviations from current Good Manufacturing Practices (cGMP) impacting the sterility assurance and overall quality of their human and veterinary sterile drug products. Key violations included profound deficiencies in preventing microbiological contamination and controlling endotoxins. Specifically, procedures for sterilizing and protecting vial stoppers were inadequate, and critical filling machine parts lacked sterilization. The firm also failed to disinfect equipment after operator interventions, contributing to potential contamination of products like Human Secretin for Injection. Furthermore, critical sterilization and filtration processes were not adequately validated, and investigations into product contamination and airborne particulate excursions were found to be superficial, lacking thorough root cause analysis and effective corrective actions. The environmental monitoring program in aseptic processing areas was deemed deficient, with inadequate continuous monitoring, inappropriate acceptance criteria, and issues with sampling specificity. Facility and equipment issues were widespread, including a non-compliant Water for Injection (WFI) system with microbial contamination and leaks, use of uncharacterized steam for sterilization, and persistent fungal contamination indicating ineffective cleaning. Structural problems like damaged cleanroom surfaces and improperly maintained vial washing equipment further compromised aseptic conditions. Finally, a veterinary drug product was distributed without an established expiration date. Bell-More Labs, Inc. is required to implement comprehensive corrective and preventive actions to address these serious compliance issues.