Inspections, Compliance, Enforcement, and Criminal Investigations
The Best Chocolate In Town 8/8/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
300 River Place
Detroit, MI 48207
August 8, 2011
Ms. Elizabeth A. Garber
The Best Chocolate in Town
880 Massachusetts Avenue
Indianapolis, IN 46204
Dear Ms. Garber:
The U.S. Food and Drug Administration (FDA) inspected your food facility located at 880 Massachusetts Avenue Indianapolis, Indiana, on May 24 and May 25, 2011. The inspection found significant violations of the FDA’s Current Good Manufacturing Practice (CGMP) regulations for manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations Part 110 (21 CFR Part 110). These violations cause the foods manufactured at your facility to be adulterated within the meaning of section 402(a)(4) of the of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4), in that they were prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. In addition, we have reviewed the labels for your products and have determined that your Pecan Turtles and Chocolate Covered Oreo Cookies are misbranded within the meaning of Section 403 of the Act, 21 U.S.C. § 343. You may find the FD&C Act and FDA’s regulations through links on FDA’s home page at www.fda.gov.
Current Good Manufacturing Practice Violations
Our inspection of your facility revealed the following violations of the CGMP regulation (21 CFR 110):
In order to comply with 21 CFR 110.80, all reasonable precautions must be taken to ensure that production procedures do not contribute to contamination from any source. The production procedures your firm uses in manufacturing food are not adequate to ensure that preceding products do not contaminate subsequent products. Specifically:
- Our investigator observed the manufacture of a product containing pecans (Pecan Turtles) followed by a non-nut containing product (Chocolate Covered Oreo Cookies). Specifically, the Milk Chocolate Pecan Turtles were hand-dipped into a tempering machine. After the Pecan Turtle batch was complete, the same piece of equipment was used to hand dip Chocolate Covered Oreo cookies, a non-nut containing product, without either a cleaning or segregation method to prevent cross contamination of tree nut allergens into a non-nut containing product. The sole method that you use to control cross-contamination between nut and non-nut products is visual inspection and hand removal of nuts in the tempering machine. This procedure does not sufficiently prevent allergen residue from contaminating non-nut products.
- In addition, during our inspection we collected production records for the operation of your dipping station during April and May 2011. These records indicate that your firm does not sequence your product (i.e., run non-allergen containing products prior to allergen containing products) to minimize the potential for cross-contamination. Of particular concern is your manufacture of peanut-containing products, as noted in your firm’s dipping station production log, without the use of an appropriate segregation method to prevent cross-contamination.
Manufacturers are responsible for ensuring that their products are not adulterated as a result of contamination with allergens. When allergens that are not specifically formulated in a food are identified as likely to occur in the food because of manufacturing practices, the manufacturer should identify and implement controls to reduce or prevent allergen cross-contact. Examples of preventive measures include production scheduling, dedicated equipment for production runs of products for which cross-contact is a concern, and proper cleaning.
Our review of your labels found that some of your products are misbranded under section 403 of the Act, 21 U.S.C. § 343:
- Your Pecan Turtles and Chocolate Covered Oreo Cookies are misbranded within the meaning of Section 403(e)(2) of the Act, 21 U.S.C. 343(e)(2), in that they fail to bear labels declaring the net quantity of contents, as required under 21 CFR 101.105(a).
The above violations are not meant to be an all-inclusive list of the violations at your facility. You are responsible for ensuring that all of your products are in compliance with the applicable statutes and regulations administered by the FDA. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure or injunction.
In addition to the violations discussed above, we have the following comment. During the inspection, you informed the FDA inspector that you might apply precautionary labeling to your products stating that your products may contain nuts or that they are manufactured in a facility that produces nuts. Precautionary labeling, however, must not be used in lieu of adherence to good manufacturing practices.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should include each step taken or that will be taken to correct the violations and prevent recurrence. You should include in your response documentation 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.
Your response should be directed to Cicely N. Vaughn, Compliance Officer, U.S. Food and Drug Administration at 300 River Place, Suite 5900 Detroit, MI 48207. If you have any questions about this letter, please contact Compliance Officer Vaughn at 313-393-8297.
Keith J. Jasukaitis
Acting District Director
Detroit District Office
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