FDA EIR - Whitmore Family Enterprise, LLC dba Taza Chocolates - February 03, 2023

A comprehensive FDA inspection of Whitmore Family Enterprises, LLC, operating as Taza Chocolate in Somerville, MA, occurred on September 30 and October 13, 2014. Conducted under the Domestic Food Safety Compliance Program, the inspection revealed several significant violations of Good Manufacturing Practices (GMPs) outlined in 21 CFR Part 110, with some issues noted as repeat observations from a prior inspection.Main deficiencies included a pervasive failure to prevent cross-contamination, particularly regarding allergens, as equipment like holding tanks, roasters, and grinders were not adequately cleaned between allergen-containing and allergen-free product runs. The firm also failed to protect finished food from raw material contamination by using unwashed containers for both raw and roasted cocoa beans. Additional contamination risks were identified from an unverified plastic chocolate mold, grime-covered fans and frayed wood in the cooling tunnel, unhygienic storage of raw cocoa beans directly on the floor, and a damaged cocoa butter tank cover. Furthermore, the facility had inadequate aisle widths, hindering proper cleaning.The Production Manager was issued an FDA-483 (Inspectional Observations) and committed to providing a written response to the District within 15 business days, detailing proposed corrective actions. The FDA indicated that the presence of repeat violations would significantly influence the inspection's final disposition.