FDA 483 - Steriscience SP. Z O.O. - April 28, 2023

During an inspection conducted from April 17 to April 28, 2023, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Steriscience SP. Z O.O., a sterile drug manufacturer located in Warsaw, Poland. The inspection revealed several deficiencies in the company's manufacturing and quality control processes, indicating a need for improved adherence to Good Manufacturing Practices. Three significant observations were noted. Firstly, the training and qualification program for visual inspectors of finished drug products was found to be inadequate. The test kits used did not cover the full range of vial sizes or types of defects encountered, directly contributing to instances where underfilled vials and contaminated products reached international markets. Secondly, the firm's laboratory controls for microbial enumeration testing of active pharmaceutical ingredients lacked scientifically sound procedures. Specifically, the temperature of culture media was not controlled or measured, and positive controls were absent, raising concerns about the reliability of sterility testing. Finally, procedures for preventing microbiological contamination in sterile drug products were insufficient. The method for trending bioburden data was not representative of actual manufacturing conditions, often excluding critical data points without a documented rationale, particularly for an ingredient used in aseptically filled injectable drugs. Steriscience SP. Z O.O. is required to address these observations promptly by implementing comprehensive corrective and preventive actions to ensure the quality, purity, and sterility of its drug products.