Thornton Industries, Inc. – FDA 483, Mar 4, 2020

Thornton Industries, Inc. in Morris, IL, a drug manufacturer, was inspected by the FDA and received a Form 483 with four observations. The inspection revealed deficiencies in written procedures for sampling and testing, inadequate in-process controls and process validation, uncontrolled access to labeling materials, and a lack of identity testing for drug components. These issues indicate significant deviations from current Good Manufacturing Practices.