Few in Indianapolis take exception to the claim made in the name of the business called “The Best Chocolate In Town.”

In print and website reviews, Indianapolis residents are giddy about the chocolate products coming out of the food manufacturing facility on Massachusetts Avenue near the intersection of interstates 65 and 70.

But “The Best Chocolate in Town” was not adhering to  “Current Good Manufacturing Practices,” according to the U.S. Food and Drug Administration, when the Indy candy factory was inspected by FDA last May 24 and 25.

In an Aug 8 warning letter to The Best’s Elizabeth A. Garber, FDA said that inspection found employees were not doing enough to ensure that nuts used in some chocolates were not coming in contact with the nut-free chocolates.

For example, the inspector said the same equipment used to hand dip the milk chocolate pecan turtles was then used to dip the chocolate-covered Oreo cookies without a cleaning or segregation method to remove all traces of tree-nut allergens. Visual inspection and hand removal of any nuts from the tempering machine was not sufficient to remove allergen residue, the warning letter stated.

“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,” the warning letter added. “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.”

The warning letter said: “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.”

During the inspection, FDA said its inspector was told that the company might apply precautionary labeling to products stating that the chocolates might contain nuts or that they were manufactured in a facility that produces nuts.

“Precautionary labeling, however, must not be used in lieu of adherence to good manufacturing practices, ”  the warning letter said.

The Detroit district office of the FDA asked “The Best Chocolate in Town” to respond within 15 working days with information on how the violations were being corrected and how it plans to prevent any recurrence.

  • Elizabeth Garber

    There is a false statement in the warning letter.
    The quote: “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.” is false.
    We do not and never have run peanut-containing products on our machinery. Unfortunately, no one called us to be sure the letter was accurate. If someone had called, I could explain why the letter might state this. We make nut clusters, which we document in our production log. The chocolate is scooped from the machine and placed in a bowl where the nut clusters are formed. No peanuts ever go into the chocolate machine. We document the product in the production log so we have a record of it being made, even though it doesn’t run through the machine.
    I am the owner of The Best Chocolate in Town. My company is a 1,900 square foot shop in downtown Indianapolis where all of our chocolates are made by hand. I have 2 full-time employees and up to 10 part-time employees during the busy holiday season. We are a very small company in the manufacturing world. Just to put it in perspective 18.8% of last year’s business was wholesale business. That’s $61,229 of our business last year. Because we make and sell some of our products wholesale, we are subject to inspection by the FDA. We do take food safety seriously and have worked to come into compliance over the years in a way that I thought was acceptable to the FDA.
    We do care about public safety. We are inspected by both the county and state. We adhere to county and state rules. We had previously been under the impression that we were taking appropriate actions to make the public aware of allergens through labeling. Not until the FDA inspected and sent this warning letter, did we discover that this is not satisfactory. After our FDA inspection in November, we put signs on our front door indicating that we process nuts in our facility and that we use the same machinery to process nuts as non-nut items. We have everything in our shop clearly marked as to what the product contains and have educated staff that can answer the public’s questions about any ingredients and allergens that might be in a product. We have ingredient labels that go on all products that are sold to retailers and we were in the process of updating the labels to include a statement indicating that we use nuts and tree nuts in our facility and that they are processed on the same machinery. I just learned, as the author of this article did, that the labeling plan is not good enough. We are certainly working on becoming compliant. I have questions about the warning letter and have left a message with the listed compliance officer, but have not yet received a return call.
    If you or anyone else has any other questions about how we are handling compliance, they are welcome to email me at trufflebiz@aol.com . I’m sure you’ll see our response to the FDA’s letter on the FDA web site when they post it.
    Elizabeth Garber
    Owner, President, CEO, CFO, Head of PR, Head of HR, Purchasing, Accounts Payable, Accounts Receivable, Head of Safety and Compliance, Marketing and Chocolatier