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ITW Dymon Jan 11, 2017

ITW Dymon - Close Out Letter 1/11/17

ITW Dymon



Black HHS-Blue FDA Logo



Kansas City District Office
8050 Marshall Drive - Suite 205
Lenexa, Kansas 66214-1524

January 11, 2017

CMS CASE 494201

Mr. Paul M. Taylor
Vice President and Group General Manager
ITW PRO Brands
805 E Old 56 Hwy
Olathe, KS 66061


Dear Mr. Taylor:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, dated October 19, 2016 (CMS Case: 494201). Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action


Eric Mueller, Compliance Officer
FDA Kansas City District