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

An FDA inspection conducted from January 23-31, 2024, at Biotechnologinės farmacijos centras Biotechpharma UAB, a drug substance manufacturer in Vilnius, Lithuania, identified significant deviations from Good Manufacturing Practices (GMP). Key issues outlined in the FDA Form 483 include inadequate contamination prevention measures, such as deficient risk assessments for product introduction and cross-contamination from different cell lines, and insufficient facility space leading to potential mix-ups and contamination during drug substance operations.

Further observations noted failures in quality control laboratory procedures, including unauthorized data manipulation and retesting without proper justification or client approval. Laboratory controls were found lacking, with unverified endotoxin detection methods, inconsistent instrument use, and a failure to investigate root causes for recurring test failures. Microbiological contamination control was deemed insufficient due to problematic in-process sampling and a lack of action on increasing environmental monitoring trends. The company also demonstrated ineffective corrective and preventive actions (CAPA) for previous quality issues, leading to recurrences, and deficiencies in equipment cleaning validations and computer system validation. Biotechpharma UAB is required to respond with a comprehensive plan detailing corrective and preventive actions to address these observations and ensure compliance with regulatory standards.