- Walnut Creek Kitchens, Inc.
- Issuing Office:
- Cincinnati District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2775
Via United Parcel Service
November 17, 2014
Mark Coblentz, Owner
Walnut Creek Kitchens, Inc.
2617 State Route 39
Walnut Creek, Ohio 44687
Dear Mr. Coblentz:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your food manufacturing facility located at 2617 State Route 39, Walnut Creek, Ohio 44687, on June 10 through June 30, 2014. During that inspection we found you had deviated from Title 21 of the Code of Federal Regulations
, Part 110, (21 CFR 110), Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Human Food. Based on the inspection findings, your smoked cheeses are adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)] in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. During the inspection of your facility, product labels for your cheese products were collected. We have reviewed your product labels and find that your labels cause your products to be misbranded within the meaning of section 403 [21 U.S.C. § 343] of the Federal Food, Drug, and Cosmetic Act (the Act) and the implementing regulations under Title 21, Code of Federal Regulations
, Part 101 (21 CFR 101). You may find the Act and FDA’s regulations through links on FDA’s homepage at www.fda.gov
1. Your smoked cheeses are adulterated within the meaning of 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)], in that you failed to hold foods which can support the rapid growth of undesirable microorganisms in a manner that prevents the food from becoming adulterated, as required by 21 CFR 110.80(b)(3). Specifically, on June 10 and 11, 2014, our investigator observed the manufacturing process for your smoked flavored cheese products. You were observed applying liquid smoke to cheese blocks that are subsequently stored overnight for approximately 12-16 hours at temperatures outside of refrigeration (i.e. 68-69°F).
We acknowledge receipt of your email dated June 16, 2014, regarding the storage of hard and processed cheese products. However, you have not provided adequate information to support your claim that hard and processed cheeses do not support rapid growth of undesirable microorganisms.
1. Your Smoked Horseradish Pasteurized Process Cheese Food, Smoked Habanero Pepper Pasteurized Process American Cheese with Habanero Peppers, and Smoked Cheddar Pasteurized Process Cheddar Cheese Food products are misbranded within the meaning of 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the product labels are false and misleading. For example, your Smoked Horseradish Pasteurized Process Cheese Food, Smoked Habanero Pepper Pasteurized Process American Cheese with Habanero Peppers, and Smoked Cheddar Pasteurized Process Cheddar Cheese Food product labels declare “smoked” as a part of the statement of identity; however, according to the establishment inspection report the products do not go through a smoking process but rather have liquid smoke applied to the surface of the cheese. The products should not include the term “smoked” in the statement of identity but “with added smoke flavor,” “smoke flavored,” or with “natural smoke flavor” would be permissible.
2. Your Smoked Horseradish Pasteurized Process Cheese Food product is misbranded within the meaning of 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] because the labels fail to declare the common or usual name of the food. Specifically, “Horseradish Pasteurized Process Cheese Food” is not an appropriate common or usual name for a product that does not contain any horseradish, but rather horseradish flavor [21 CFR 101.3(b)].
3. Your Smoked Cheddar Pasteurized Process Cheddar Cheese Food and Smoked Habanero Pepper Pasteurized Process American Cheese with Habanero Peppers products are misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required by 21 CFR 101.4. For example:
- Your Smoked Cheddar Pasteurized Process Cheddar Cheese Food product is manufactured using water, cream, sorbic acid, skim milk, paprika, and enzymes; however, you fail to list these ingredients on the finished small product label. Your Smoked Cheddar Pasteurized Process Cheddar Cheese Food large product label list “cheese” as an ingredient; however, the product is manufactured using “cheddar cheese” which is a standardized food as specified in 21 CFR 133.113.
- Your Smoked Habanero Pepper Pasteurized Process American Cheese with Habanero Peppers product is manufactured using sorbic acid, oleoresin capsicum, and vegetable color; however, you fail to list these ingredients on your small finished product label.
- Your Smoked Habanero Pepper Pasteurized Process American Cheese with Habanero Peppers small product label lists titanium dioxide; however, according to the original cheese product label this ingredient is not in the product.
The requirement to list these component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after common or usual name of the main ingredient, or by listing the component ingredients without listing the ingredient itself. Under the first alternative, the component ingredients; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
In addition to violations cited above, we have the following comment:
- We note that the majority of your small labels do not contain the “Keep Refrigerated” statement. FDA has evaluated labeling on foods that must be refrigerated to prevent the outgrowth of pathogens. FDA’s view is to divide refrigerated products into three groups; Group A, B and C, based on pH, water activity and thermal processing or other treatment.
Additionally, the inspection referenced above identified violations materially related to the food safety requirements of the Act. Accordingly, Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs associated with reinspection. A reinspection is one or more inspections conducted following an inspection that identified noncompliance materially related to the food safety requirements of the Act, specifically to determine whether compliance has been achieved. Reinspection costs include all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees. FDA will assess and collect fees associated with this reinspection in accordance with Section 743 of the Act.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations. You should include in your response documentation such as your revised labels, related processing corrective actions, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to the Food and Drug Administration, Attention: Allison C. Hunter, Compliance Officer, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have questions regarding any issues in this letter, please contact Allison C. Hunter, Compliance Officerat (513) 679-2700 extension 2134.
Paul J. Teitell