CLOSEOUT LETTER
LumiQuick Diagnostcs Inc.
- Recipient:
- LumiQuick Diagnostcs Inc.
United States
- Issuing Office:
United States
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| Food and Drug Administration San Francisco District 1431 Harbor Bay Parkway Alameda, CA 94502 Telephone: (510) 337-6700 FAX: (510) 337-6703 |
Department of Health and Human ServicesOctober 19, 2015
Chang F. Yu, President
LumiQuick Diagnostics, Inc.
2946 Scott Blvd.
Santa Clara, CA 95054
Dear Mr. Yu:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letters 392748 dated July 31, 2013 and 423587 dated April 1, 2014. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letters. 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.
Sincerely,
/S/
Lawton W. Lum
Director of Compliance