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  5. Mexicantown Bakery, Inc. dba Mexicantown Wholesale - Close Out Letter 1/25/16
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CLOSEOUT LETTER

Mexicantown Bakery, Inc. dba Mexicantown Wholesale Jan 25, 2016

Mexicantown Bakery, Inc. dba Mexicantown Wholesale - Close Out Letter 1/25/16


Mexicantown Bakery, Inc. dba Mexicantown Wholesale

  

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

Public Health Service
 Food and Drug Administration
Detroit District
300 River Place
Suite 5900
Detroit, MI 48207
Telephone: 313-393-8100
FAX: 313-393-8139

January 25, 2016


Mr. Omar M. Hernandez, President
Mexicantown Bakery, Inc.
8100 Radcliffe Street
Detroit, MI 48210

Dear Mr. Hernandez:

The Food and Drug Administration acknowledges receipt of your response to the FDA 483, which was issued on December 11, 2015 following the follow-up investigation of your bakery facility located at 8100 Radcliffe Street, Detroit, MI. Your response documents were received by this office on December 11, 2015 via email.

We have evaluated the corrective actions which you described in your response letter and they appear to adequately address the 483 observations. It appears that you have made some changes or promised changes to your operation, which include the following: purchasing pan rack covers, specific training refreshers, and registering in accordance with the Bioterrorism Preparedness and Response Act 2002. We hope that your commitment to the above proposed changes will prevent any future observations. No further response is necessary at this time; however, you are always free to provide us with any new information that you would like us to be aware of regarding your facility.

It is FDA policy to issue a "Close-out Letter" to firms that have achieved this goal. You will receive the "Close-out Letter" under separate cover and will indicate your state of compliance. This letter will be posted on our website (www.fda.gov) along with the Warning Letter. Your response letter and any future correspondence will be placed in our permanent establishment files. Thank you for your cooperation.


Sincerely,

/S/

LCDR Kelli L. Wilkinson
Compliance Officer
Detroit District Office