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  5. SYNECCO LTD. - Close Out Letter 4/22/15
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CLOSEOUT LETTER

SYNECCO LTD. Apr 22, 2015

SYNECCO LTD. - Close Out Letter 4/22/15


SYNECCO LTD.

  

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

 
 Food and Drug Administration
10903 New Hampshire A venue
White Oak Building 66
Silver Spring, MD 20993

 

Via United Parcel Service

 

APR 22, 2015
 


Gary Yu
Quality Manager
Synecco (Ningbo)
1604 Room, Bona Mansion
No. 456 Middle Taikang Road
Middle Taikang Road
315300 Ynzhou, Ningbo
China


Dear Mr. Yu:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #410611. 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/

Carl Fischer, Ph.D.
Director
Division of International Compliance
Operations
Office of Compliance
Center for Devices and Radiological Health