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

An FDA inspection of Steriscience Sp. z o.o. in Warsaw, Poland, revealed significant deficiencies in their manufacturing processes for sterile drug products. Observations included inadequate training and qualification of visual inspectors, scientifically unsound laboratory controls for microbial enumeration, and insufficient procedures to prevent microbiological contamination. These issues raise concerns about the quality and sterility assurance of their drug products.