FDA WARNING_LETTER - Oxford Falls - February 09, 2010

On February 3-4 and 9, 2010, an FDA inspection of Oxford Falls, Inc.'s acidified food manufacturing facility in Starkville, Mississippi, revealed serious deviations from FDA's Low-Acid Canned Food regulations (21 CFR 108 and 113), Acidified Foods regulations (21 CFR 108 and 114), and Current Good Manufacturing Practice (CGMP) provisions (21 CFR 110). These failures render the firm's acidified foods adulterated under Section 402(a)(4) of the Act and could lead to emergency permit control provisions under Section 404.

Key violations include: - Failure to provide FDA with process and procedure information for acidified foods, specifically not responding to a February 5, 2009, request for details on process filings 2009-01-21/001-011, including raw pH, container closure pasteurization, fill temperatures, hold times, and F and z values. - Numerous labeling violations for products like Remoulade Salad Dressing, Blackberry Wasabi Sauce, Cranberry Wasabi Sauce, and Pomegranate Wasabi Sauce. These include: - Failure to list sub-components of multi-component ingredients (e.g., Ketchup, Mustard) and using brand names instead of common names (e.g., "Heinz Ketchup").