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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Horiba Instruments, Inc dba Horiba Medical - Close Out Letter 7/3/13

  

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

Public Health Service
Food and Drug Administration
 Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506

Telephone: 949-608-2900
             FAX: 949-608-4415

 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

 

July 3, 2013

 

Riad R. Abuelafiya,
Vice President and General Manager
Horiba Instruments, Inc., dba Horiba Medical
34 Bunsen
Irvine, CA 92618-4210


Dear Mr. Abuelafiya:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter (WL #31-12 dated July 25, 2012). 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,

/S/

Blake Bevill, Acting District Director
Los Angeles District