- Mexicantown Bakery, Inc. dba Mexicantown Wholesale
Department of Health and Human Services
|Public Health Service|
|Food and Drug Administration|
300 River Place
Detroit, MI 48207
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.
LCDR Kelli L. Wilkinson
Detroit District Office