FDA WARNING_LETTER - Middle East Bakery, Inc. - June 06, 2014

On May 14, 15, 19, 21, 29, and June 6, 2014, the FDA inspected Middle East Bakery, LLC in Lawrence, MA. The inspection revealed significant violations of food labeling regulations (21 CFR 101) and failure to report Reportable Foods to the Reportable Food Registry within 24 hours, as required by Section 417(d)(1) of the Act.

Specifically, "Market Basket brand Dairy-Free Gluten-Free Pancakes" were misbranded because they were labeled "Dairy-Free" but contained milk in several batches. Both "Market Basket brand Dairy-Free Gluten-Free Pancakes" and "liveGfree brand Blueberry Pancakes" failed to declare milk as a major food allergen. "liveGfree brand Blueberry Pancakes" were also misbranded for claiming "ALL NATURAL" while containing synthetic sodium acid pyrophosphate. Furthermore, both products' labels failed to list all ingredients and sub-ingredients in descending order of predominance by weight, and used incorrect common or usual names for some ingredients.

The firm failed to report two instances of undeclared milk in "Market Basket brand Dairy-Free Gluten-Free Pancakes" and "liveGfree brand Blueberry Pancakes" to the Reportable Food Registry within the required 24-hour timeframe, despite determining the issue and receiving consumer complaints.

The firm's response to the FDA 483 was