Mirrotek International, LLC – FDA Warning Letter, Sep 30, 2011

An FDA inspection of Mirrotek International, LLC, located in Passaic, NJ, was conducted on September 27, 28, & 30, 2011, verifying the firm manufactures and distributes acidified food products, specifically Iron Chef® General Tso's Sauce and Glaze and Sesame Garlic Sauce and Glaze. The inspection revealed significant violations of the Federal Food, Drug and Cosmetic Act (the Act) and federal regulations for acidified foods (21 CFR 108 and 21 CFR 114), rendering the products adulterated under section 402(a)(4) of the Act.

Key violations include: 1. Failure to register the firm's information (name, place of business, location) with the FDA within 10 days of engaging in acidified food manufacturing, as required by 21 CFR 108.25(c)(1). The firm has been manufacturing since January 2011 without registration. 2. Failure to provide scheduled process information for each acidified food in each container size to the FDA, as required by 21 CFR 108.25(c)(2). 3. Personnel involved in acidification, pH control, heat treatment, and critical factors were not supervised by a person who satisfactorily completed an FDA-approved school, violating 21 CFR 108.25(f). 4