FDA 483 - Biotechnologinės farmacijos centras Biotechpharma UAB - January 31, 2024

The FDA inspected Biotechnologinės farmacijos centras Biotechpharma UAB, a drug substance manufacturer, from January 23 to January 31, 2024. This inspection resulted in an FDA Form 483, detailing several significant observations indicating non-compliance with Current Good Manufacturing Practices (cGMP) standards. Key issues included a lack of assurance in preventing contamination, with risk assessments not based on health-based exposure limits and insufficient detail on cross-contamination mitigation. The facility exhibited inadequate space, leading to overcrowded filling areas and material transfers that presented contamination risks. Furthermore, the company failed to follow its own written quality control laboratory procedures, such as unauthorized manipulation of test parameters and retesting without proper justification or client approval. Laboratory controls were deemed inadequate due to unverified endotoxin detection methods, use of unlisted instruments, and a failure to investigate frequent system suitability failures. Ineffective corrective and preventive actions (CAPAs) were noted, with recurring deviations, like untimely endotoxin sample testing, persisting without thorough investigation or product impact assessments. Procedures to prevent microbiological contamination were insufficient, evidenced by sampling methods increasing contamination risk and a failure to address upward trends in environmental monitoring. Additionally, equipment cleaning validations were inadequate, lacking swab samples for critical areas, and a crucial raw material lacked periodic identity testing. Biotechpharma UAB is required to implement comprehensive corrective actions to address these observations and ensure the quality, safety, and integrity of its drug substances.