Inspections, Compliance, Enforcement, and Criminal Investigations
Proportional Technologies, Inc - Close Out Letter 8/17/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3128
August 17, 2012
RETURN RECEIPT REQUESTED
Jeffrey L. Lacy, Ph.D.
Owner and President
Proportional Technologies, Inc.
8022 El Rio Street
Houston, Texas 77054
Dear Dr. Lacy:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, 2011-DAL-WL-09, issued on March 31, 2011. 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
Director, Compliance Branch
Dallas District Office