Inspections, Compliance, Enforcement, and Criminal Investigations
Millar Instruments, Inc. Close out Letter 7/5/13
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3128
July 5, 2013
Mr. Glenn Craig Thummel
President and Chief Executive Officer
Millar Instruments, Inc.
6001-A Gulf Freeway
Houston, TX 77023
Dear Mr. Thummel:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 2012-DAL-WL-22, May 7, 2012. 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 should violations be observed during a subsequent inspection or through other means.
Shari J. Shambaugh
Dallas District Compliance Branch