FDA WARNING_LETTER - Bagels Forever, Inc - April 21, 2011

On April 13, 14, and 21, 2011, the FDA inspected Bagels Forever, Inc.'s facility in Madison, Wisconsin, and found significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR 110), causing their food to be adulterated under 21 U.S.C. § 342(a)(4).

Specific CGMP violations included: 1. **Inadequate Cleaning of Food Contact Surfaces (21 CFR 110.35(d)):** Food contact surfaces of mixers, dough formers, separators, and canvas conveyor belts were only scraped or brushed at the end of the day, leaving significant product residue and chunks of raw dough. 2. **Cross-Contamination During Production (21 CFR 110.80(b)(7)):** The firm used one manufacturing line for 26 different bagel varieties without cleaning equipment between varieties, leading to crusted dough and residue on equipment. Production procedures and sequencing were inadequate to prevent contamination, especially concerning allergenic ingredients.

Additionally, a review of product labeling revealed misbranding violations under 21 CFR 101, causing products to be misbranded under 21 U.S.C. § 343: 1. **False and Misleading Claims (21 U.S.C. § 343