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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Laglove Sdn Bhd (M) aka LA Glove - Close Out Letter 12/16/11

  

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

 

DEC 16 2011


Mr. Govindasamy Baskaran
Managing Director
Laglove (M) Sdn. Bhd.
Lot 478 Jalan Simpang Salak
Off Batu 13, Jalan Cheras
43000 Kajang, Selangor D.E., Malaysia


Dear Mr. Baskaran:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter, issued January 20, 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


cc:

Mr. Nicholas Twitchen
Director of Global Quality Assurance
The Female Health Company (UK) Pic
3 Mansfield Road
West Avenue Business Park

 

(U.S. Agent)
Ms. May Sun
Director
Digitcare Corp.
2999 Overland Ave., Suite 209
Los Angeles, CA 90064