FDA WARNING_LETTER - Galati Cheese Company Ltd. - January 11, 2011

On January 10 and 11, 2011, the FDA inspected Galati Cheese Company Ltd.'s facility in Windsor, Ontario, Canada. The inspection revealed a serious violation of the Current Good Manufacturing Practice (CGMP) regulation, 21 CFR Part 110, rendering their cheese products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

The specific violation identified was the failure to store and transport finished food under conditions protecting against contamination, as required by 21 CFR 110.93. Galati Cheese Company stored finished ready-to-eat ricotta cheese in plastic pails with pre-drilled, ragged, and non-cleanable orifices, allowing direct contact between the cheese and these surfaces. The company's January 31, 2011, response, stating continued use of these pails, was deemed inadequate because the pails cannot be adequately cleaned to prevent contamination. The FDA suggested alternatives like properly designed and cleanable cheese molds.

Galati Cheese Company must respond in writing within thirty working days, outlining specific corrective actions. Failure to respond adequately may result in further action, including refusal of admission of ricotta cheese products into the U.S. under Section 801(a) of the Act, potentially leading to detention without physical examination (DWPE). The letter emphasizes the company's responsibility to ensure overall compliance with