FDA WARNING_LETTER - Lucky Fortune Cookies, Inc. - February 28, 2013

On August 30, 2013, the FDA issued a Warning Letter to Lucky Fortune Cookies, Inc. following an inspection on February 26 and 28, 2013, at their Jessup, MD facility, a manufacturer of ready-to-eat fortune cookies. The inspection revealed significant violations of FDA's Current Good Manufacturing Practice (CGMP) regulations (21 CFR 110), causing their food to be adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). Additionally, label review found significant violations of food labeling regulations (21 CFR 101), resulting in misbranded products under section 403 of the Act.

CGMP violations included: 1. Failure to maintain physical facilities in repair (21 CFR 110.35(a)): Peeling and missing ceiling panels were observed directly above the manufacturing area where finished cookies were exposed. 2. Failure to protect against inclusion of metal and extraneous material (21 CFR 110.80(b)(8)): A metal piece intentionally passed through the metal detector undetected.

Misbranding violations included: 1. Failure to declare the major food allergen "wheat" (section 403(w) of the Act) on Fortune Cookie (5.5 LBS. and individually wrapped) products, despite using wheat