FDA 483 - Illinois Tool Works Inc - April 01, 2022

Illinois Tool Works Inc. in Olathe, KS, was cited with six observations during an FDA inspection of its drug manufacturing facility. The findings highlight significant deficiencies, many of which were repeat observations, including inadequate quality control unit oversight of contract manufacturers, lack of microbiological testing for drug products, and insufficient written procedures for manufacturing, labeling, and data integrity. These issues collectively indicate a failure to adhere to current Good Manufacturing Practices.