FDA WARNING_LETTER - Castle Cheese, Inc. - December 11, 2012

On July 11, 2013, the FDA issued a Warning Letter to Castle Cheese, Inc. following an inspection from November 14 to December 11, 2012. The inspection revealed significant violations regarding the company's International Packing Parmesan Cheese, (b)(4) Romano 100% Grated Cheese, and (b)(4) 100% Grated Parmesan Cheese products.

The products were deemed adulterated under 21 U.S.C. § 342(b)(1), (b)(2), and (b)(4). Specifically, milk was partially omitted and replaced by (b)(4) and (b)(4), and the fat source in International Packing Parmesan Cheese was (b)(4) instead of milk fat. Other cheese varieties were substituted wholly or in part for the declared cheese, including (b)(4) cheeses for Parmesan and a mix of (b)(4), (b)(4), (b)(4), and (b)(4) for Romano and Parmesan. Additionally, cellulose and/or starch were added to increase bulk and weight.

The products were also misbranded under 21 U.S.C. § 343(a)(1), (b), (g)(1), and (i)(2). Labels falsely declared products as Parmesan or Romano cheese when they were mixtures of trimmings and other ingredients, with