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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Home Care Teclmology USA Inc - Close Out Letter 10/19/12

  

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

VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED


October 19, 2012


Mr. Qi (Phillip) Zhu, Owner
Home Care Technology USA Inc
560 West Main St. #C827
Alhambra, CA 91801

Dear Mr. Zhu:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter, WL # 18-12, dated 02/09/12. Based on our evaluation, it appears that you have addressed the violation(s) 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.

Finally, our inspection ending 09/11/12 disclosed that you no longer engage in the labeling or distribution of medical devices. If that is the case, you should consider updating your medical device registration status at
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/
RegistrationandListing/default.htm. In addition, you should be aware that you may have record keeping and device follow up responsibilities for devices already distributed.

Sincerely,
 

/S/

Alonza E. Cruse
District Director
Los Angeles District