FDA 483 - Scientific Protein Laboratories, LLC - January 10, 2020

An FDA inspection of Scientific Protein Laboratories, LLC in Waunakee, WI, an API manufacturer, revealed three significant observations. The firm was cited for inadequate procedures for investigating Out of Specification results, insufficient quality control unit procedures, and failure to follow written production and process control procedures, specifically regarding change control. These issues highlight deficiencies in the firm's quality management system.