FDA WARNING_LETTER - Whatsa Bagel, Inc. - February 14, 2013

On May 14, 2013, the FDA issued a Warning Letter to Whatsa Bagel, Inc. following an inspection from February 6-14, 2013. The inspection found significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR 110) and food labeling regulations (21 CFR 101), rendering their ready-to-eat (RTE) bagels adulterated and misbranded.

Adulteration violations included the use of porous, difficult-to-clean plywood proofboards and baking boards (21 CFR 110.40(a)), which can shed particles and contaminate food. Additionally, the firm failed to clean and sanitize these boards and plastic trays between uses (21 CFR 110.35(a)). The firm's response to replace plywood proofboards with plastic trays was noted, but it did not address the continued use of baking boards.

Misbranding violations for bulk, RTE bagels included failure to declare all major food allergens (wheat, eggs, milk, soy, tree nuts) as required by 21 U.S.C. § 343(w). Products were packaged in unlabeled paper bags within plastic bags. Furthermore, the bagels lacked a statement of identity (21 CFR 101.3(a)), and failed to bear the manufacturer's name and place of business (21 CFR