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CLOSEOUT LETTER

Chemolee Lab Corporation Dec 14, 2017

Chemolee Lab Corporation - Close Out Letter 12/14/17


Recipient:
Chemolee Lab Corporation


United States

Issuing Office:

United States


 

  

Black HHS-Blue FDA Logo

 

Office of Pharmaceutical Quality Operations, Division II
4040 North Central Expressway, Suite 300
Dallas, Texas 75204-3158

 
 

December 14, 2017

UPS OVERNIGHT MAIL

Mr. Jerome Lee, Director of Operations
Chemolee Lab Corporation
3820 Conflans Road
Irving, Texas 75061-3915

Dear Mr. Lee:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, 2016-DAL-WL-12, issued on February 23, 2016. 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.

If you have additional questions, please contact me at 214-253-5288.

Sincerely,
/S/
John W. Diehl
Acting Director, Compliance Branch
Office of Pharmaceutical Quality Operations, Division II