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CLOSEOUT LETTER

Ambco Electronics, A California Corp


Ambco Electronics, A California Corp

  

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

 
 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

July 2, 2015

Dennis L Daniels, President and CEO
Ambco Electronics
15052 Red Hill Ave, Suite D
Tustin, CA, 92780

Dear Mr. Daniels:

The Food and Drug Administration has evaluated your corrective actions to FDA Warning Letter (WL) #36-14, dated September 26, 2014, including your written responses to the WL, and the results of our follow up inspection that closed May 5, 2015. Based on our evaluation, it appears you have addressed the violations contained in the subject 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/

Alonza E. Cruse, Director
Los Angeles District