FDA 483 - First Priority, Inc. - November 18, 2021

First Priority, Inc. in Elgin, IL, an animal drug manufacturer, was inspected by the FDA and received a Form 483 with seven observations. The inspection revealed significant deficiencies in equipment cleaning validation, computer system controls, stability testing adherence, and out-of-specification investigation procedures. Additionally, issues were noted with production and process control procedures, equipment design, and the timely submission of field alert reports for product defects.