FDA 483 - BIOTECHPHARMA BIOTECHNOLOGINES FARMACIJOS CENTRAS UAB - January 31, 2024

The FDA inspected Biotechnologines farmacijos centras Biotechpharma UAB, a drug substance manufacturer in Vilnius, Lithuania, and identified significant deficiencies. Observations included inadequate contamination prevention measures, insufficient facility space, and failures to adhere to written quality control laboratory procedures. The firm also demonstrated a lack of thorough investigations for deviations, inadequate laboratory controls for endotoxin testing, and deficiencies in microbiological contamination prevention and equipment cleaning validations.