CLOSEOUT LETTER
Chemolee Lab Corporation
- Recipient:
- Chemolee Lab Corporation
United States
- Issuing Office:
United States
Office of Pharmaceutical Quality Operations, Division II | |
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