FDA 483 - Particle Size Technology, Inc. - November 13, 2023

Particle Size Technology, Inc. in Quakertown, PA, a contract API manufacturer, was cited with two significant observations during an FDA inspection. The firm failed to establish adequate written procedures for cleaning API manufacturing equipment, including clean hold times and detailed cleaning steps. Additionally, the inspection revealed insufficient controls over computerized laboratory systems, allowing analysts unauthorized access to alter electronic raw data and lacking audit trail reviews.