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U.S. Department of Health and Human Services

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Enforcement Actions

lnnolatex SDN. BHD. - Close Out Letter 1/11/12

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
Silver Spring, MD 20993

JAN 11, 2012

Mr. Goh Miah Kiat
General Manager
lnnolatex SDN. BHD.
Lot 594, Persiaran Raja Lumu
Pandamaran Industrial Estate
42000 Port Klang, Selangar Darul Ehsan
Malaysia

Dear Mr. Kiat:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS Case #179013, issued May 18, 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.

Sincerely yours,

/s/

Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health