FDA WARNING_LETTER - Walnut Creek Kitchens, Inc. - June 30, 2014

The FDA conducted an inspection of a food manufacturing facility at 2617 State Route 39, Walnut Creek, Ohio, from June 10-30, 2014. The inspection found deviations from 21 CFR Part 110 (CGMP), rendering smoked cheeses adulterated under section 402(a)(4) of the Act due to insanitary conditions. Specifically, smoked cheeses were held at 68-69°F for 12-16 hours after liquid smoke application, failing to prevent rapid growth of undesirable microorganisms as required by 21 CFR 110.80(b)(3).

Additionally, product labels caused misbranding under section 403 and 21 CFR Part 101. Products like "Smoked Horseradish Pasteurized Process Cheese Food" were misbranded because they used liquid smoke, not a smoking process, yet declared "smoked" in the statement of identity (403(a)(1)). The "Horseradish" product was misbranded for not containing horseradish, only flavor (403(i)(1)). Furthermore, "Smoked Cheddar" and "Smoked Habanero Pepper" products failed to declare all ingredients (e.g., water, cream, sorbic acid, skim milk, paprika, enzymes, oleoresin capsicum, vegetable color) on small labels, and some listed incorrect ingredients (40