The Best Chocolate In Town – FDA Warning Letter, May 25, 2011

On August 8, 2011, the FDA issued a Warning Letter to The Best Chocolate in Town following an inspection on May 24-25, 2011, at their Indianapolis, Indiana facility. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110), rendering their food products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) due to insanitary conditions.

Specifically, the firm failed to take reasonable precautions to prevent cross-contamination, as required by 21 CFR 110.80. The investigator observed the manufacture of Pecan Turtles (nut-containing) followed by Chocolate Covered Oreo Cookies (non-nut-containing) using the same tempering machine without adequate cleaning or segregation. The firm's sole method of visual inspection and hand removal of nuts was deemed insufficient to prevent allergen residue contamination. Production records from April-May 2011 also indicated a lack of proper product sequencing (non-allergen before allergen) and inadequate segregation methods for peanut-containing products, raising concerns about cross-contamination.

Additionally, the Pecan Turtles and Chocolate Covered Oreo Cookies were found to be misbranded under Section 403(e)(2) of the Act because their labels failed to declare the net quantity of contents, as required by 21 CFR 10