FDA 483 - BIOTECHPHARMA BIOTECHNOLOGINES FARMACIJOS CENTRAS UAB - September 18, 2025

From September 12 to 18, 2025, the U.S. Food and Drug Administration (FDA) conducted an inspection of Biotechnologinės farmacijos centras Biotechpharma UAB, a drug substance manufacturer located in Vilnius, Lithuania. The inspection resulted in the issuance of a Form FDA 483, detailing four primary observations regarding the facility"s quality and safety protocols. Specifically, investigators identified concerns with equipment design, as excessive condensation in manufacturing areas created potential contamination risks and obstructed the detection of leaks. Additionally, the firm’s preventive maintenance documentation was found to be incomplete, lacking critical scheduling and extension procedures described by management. The FDA also noted deficiencies in the facility"s disinfection protocols, as efficacy studies failed to include microorganisms typically found in their specific cleanroom environment. Finally, inspectors observed improper personnel monitoring techniques during drug substance filling operations, specifically regarding how operators collected environmental samples from their hands. While these observations do not constitute a final determination of non-compliance, the company is expected to provide a formal response to the FDA. This response should outline specific corrective actions taken or planned to address these deficiencies. Failure to adequately resolve these issues may lead to further regulatory action under the federal guidelines governing drug manufacturing standards.