FDA 483 - Particle Sciences, Inc. - June 24, 2021

An FDA inspection of Lubrizol Life Science Health dba Particles Sciences Inc. in Bethlehem, PA, a sterile drug manufacturer, identified significant deficiencies across multiple areas. The firm was cited for inadequate validation of sterilization processes, unqualified manufacturing equipment, and incomplete investigations into production discrepancies. Additionally, the inspection revealed failures to adhere to written procedures for documentation, product disposition, and the management of stability study samples.