FDA 483 - Del Rey Tortilleria, Inc. - January 08, 2009

This FDA Form 483 documents observations from an inspection of Del Rey Tortilleria, Inc., a manufacturer located at 5201 W Grand Ave, Chicago, IL, conducted from December 4, 2008, to January 8, 2009. Ms. Dorothy L. De La Torre, General Manager, was issued the report.

The inspection revealed several violations related to good manufacturing practices:

1. **Improper Storage of Toxic Cleaning Compounds:** A heavy-duty cleanser was found in the tostada cooking and tamale dough mixing room on December 4, 2008, and accessible in the tortilla production area, 15 feet from flour tortilla manufacturing, on January 8, 2009. This constitutes a failure to protect against contamination of food and food-contact surfaces.

2. **Inadequate Plant Construction:** On December 4, 2008, condensate was observed dripping directly over stainless steel cooking tubs holding masa in the masa production area, indicating the plant is not constructed to prevent drip and condensate contamination.

3. **Failure to Minimize Contamination during Manufacturing, Packaging, and Storage:** * A medical inhaler was stored on a production table 5 feet from the tortilla mixer on December 4, 2008. * A plastic scoop for masa production was found directly on corn grinding equipment, and another in the