As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.

Third Synthesis Inc., dba Chicago Sweet Connections Inc.
Chicago, IL

A food firm in Chicago is on notice from the FDA for serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation including undeclared allergens.

In a Sept. 6, 2022, warning letter the FDA described a Feb. 24 through March 24 and May 3, 2022, inspection of Third Synthesis Inc.’s bakery facility in Chicago, IL.

The FDA’s inspection revealed that the ready-to-eat (RTE) cakes and paczkis manufactured in the facility are adulterated. The inspection resulted in the issuance of an FDA Form 483. Some of the firm’s significant violations are as follows:

Hazard Analysis and Risk-based Preventive Controls:

1. The firm did not appropriately evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control for their RTE cakes and paczkis, as required. Specifically:

a. The firm’s hazard analysis considered undeclared allergens at the packaging/labeling step, but determined that this hazard was not “Significant” (i.e., did not require a preventive control) because “[a]ll products contain wheat, milk, egg and soy which are known allergens. Products containing nuts or coconut, contain a unique allergen, tree nuts.” However, the facility receives, stores, and uses allergens such as wheat, milk, egg, soy, and tree nuts (including walnuts, pecans, and coconut) in production. Therefore, undeclared allergens are a known or reasonably foreseeable hazard. Further, a knowledgeable person manufacturing/processing food in their circumstances would identify undeclared allergens as a hazard requiring a preventive control. Preventive controls for food allergens include procedures, practices, and processes employed for labeling to ensure that all food allergens are included on the label.

The FDA notes that they had an allergen control program, “Allergen Control Program No: CSCB-208.” However, the firm did not have adequate allergen controls in place as evidenced by their Feb. 25, 2022 recall of paczkis and coffee cakes which did not declare allergens including wheat, milk and/or egg. Further, their allergen control program did not adequately address the monitoring of labels. The program stated that “(redacted).” This procedure did not adequately address monitoring because it does not specify the number of finished products that will be monitored or establish the frequency with which this monitoring is to be performed. Additionally, they did not implement this procedure. FDA investigators observed pre-printed labels being applied to products by a label operator who also checked that the right label was applied to the product. However, there was no “inspect[ion] by QA” and no checking that there was “proper labeling of allergenic products … in the label ingredient statement.”

Furthermore, as mentioned above, FDA investigators observed several types of paczkis and coffee cakes which did not declare allergens, including wheat, milk and/or egg. These products were recalled by the firm on Feb. 25, 2022. Their response stated that fresh finished product bakery item labels will be reviewed on a (redacted) basis and that QA is not always available to check the variety of products that are being packed and labeled. However, a (redacted) review of labels is not adequate to ensure that allergens are correctly declared on their product labels and that the right label is applied during production.

b. The firm’s hazard analysis considered allergen cross-contact at the setup and packaging/labeling steps, but determined that this hazard did not require a preventive control because their “Sanitation SOP” made contamination via equipment and workers unlikely. However, preventive controls for food allergens include procedures, practices, and processes employed for ensuring protection of food from allergen cross-contact, e.g., SSOPs such as their Sanitation SOP referenced above (see 21 CFR 117.135(c)(2)(i)). Thus, FDA would consider controls within this program to be preventive controls for allergens and not an appropriate basis to conclude that preventive controls are not needed. Further, their hazard analysis did not consider allergen cross-contact at the cake-slicing and finishing/icing steps. The firm manufactures cakes with different allergen profiles on the same day on shared equipment at these steps. Allergen cross-contact could occur in products with different allergen profiles, without appropriate controls. Therefore, allergen cross-contact is a known or reasonably foreseeable hazard. Further, a knowledgeable person manufacturing/processing food in their circumstances would identify allergen cross-contact as a hazard requiring a preventive control.

FDA notes that although they had an allergen control program, it did not adequately address cross-contact. The firm’s program stated that “(redacted).” However, this procedure is not adequate as a preventive control for allergen cross-contact because it lacks monitoring and/or verification procedures and addresses the cleaning and sanitizing of machines but not of other food-contact equipment such as spatulas, frosting platforms, and prep tables. Further, the procedure does not distinguish between allergen-containing products with different allergen profiles (e.g., two products, both containing allergens, but one contains a unique tree nut allergen).

The failure to account for foods with different allergen profiles was evident on March 1, 2022, when FDA investigators observed the manufacture of 10” Carrot Cakes (containing the allergens wheat, egg, milk, soy, and walnuts in the cooked sponge cake) and the manufacture of 10” Red Velvet Cakes (containing the allergens wheat, egg, milk, and soy). Carrot Cakes were scheduled before Red Velvet Cakes, despite the Carrot Cakes containing the unique walnut allergen. Further, FDA investigators observed an employee roll a rack of unfrosted Carrot Cakes next to the conveyor belt line. An employee at the beginning of the line used their gloved hands to grab the sides of the Carrot Cakes and transfer them to a platform for frosting. After the Carrot Cakes were frosted by a (redacted), the employee used their gloved hands to place them onto the conveyor belt line. A different employee (one of several) then removed the Carrot Cakes from the line and (redacted) to an adjacent prep table wher the cream cheese frosting was smoothed using a flat, long spatula. The employees also added additional cream cheese frosting as needed from a (redacted) on the table, using the spatula. On the same day, immediately after frosting their Carrot Cakes (which contained walnuts in the cake), the original employee, using the same gloves, switched to transferring the Red Velvet Cakes (not containing walnuts) to the frosting platform without washing the frosting platform, washing their hands, or changing gloves. These Red Velvet Cakes were then also moved from the conveyor line to the prep table for additional frosting and smoothing. The employees performed the final frosting with the same spatula, without cleaning the spatula between products, and dipped the spatulas into the same (redacted) that had been used for the Carrot Cake.

c. The firm’s hazard analysis considered pathogen contamination via equipment and workers at the cooling/depanning, cake slicing, (redacted), set up, and packaging/labeling steps, but determined that this hazard did not require a preventive control because “SSOP makes contamination via equipment and workers unlikely.” However, sanitation controls include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens and biological hazards due to employee handling. Thus, the FDA would consider controls within this program to be preventive controls for pathogens and not an appropriate basis to conclude that preventive controls are not needed. In addition, the firm’s hazard analysis did not consider pathogen contamination at the finishing/icing step. Their RTE cakes are exposed to the environment after being baked and until they are packaged. The packaged cakes do not receive a lethal treatment or otherwise include a control measure that would significantly minimize pathogens. Therefore, contamination with environmental pathogens is a known or reasonably foreseeable hazard. Further, a knowledgeable person manufacturing/processing food in their circumstances would identify environmental pathogens as a hazard requiring a preventive control.

d. The firm’s hazard analysis did not identify and evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control. Their facility manufactures cakes with walnuts, wheat flour, and raisins (e.g., Carrot Cake). These ingredients have been associated with mycotoxins. Therefore, contamination with mycotoxins is a known or reasonably foreseeable hazard. Further, a knowledgeable person manufacturing/processing food in their circumstances would identify mycotoxins as a hazard in ingredients that requires a supply-chain-applied control and would establish and implement a risk-based supply-chain program for those raw materials and other ingredients. The supply-chain program must include using approved suppliers and conducting supplier verification activities. The FDA notes that the firm has a receiving procedure, “Receiving Raw Materials document No: SOP-101,” but it did not address the use of approved suppliers, and they did not approve suppliers.

Current Good Manufacturing Practice:

2. The firm did not store or transport food, including ingredients, under conditions that protect against allergen cross-contact to comply with regulations. Specifically, on March 1, 2022, in the finished product walk-in refrigerator, FDA investigators observed the storage of finished, unpackaged 10” cakes. The cakes were stored on racks with (redacted) shelving. Cakes with coconut shavings (coconut allergen) were observed stored above lemon cakes that did not contain coconut or other tree nuts. FDA investigators also observed cake toppings stored in individual plastic trays, approximately (redacted) tall, on a rolling speed rack. Each topping had a loose piece of parchment paper placed on top of it. The tray of chopped walnuts ( an allergen) was in the middle of the rack, stored above other non-nut containing toppings such as Oreo crumbles, rainbow sprinkles, red velvet cake crumbles, and yellow cake crumbles.

Misbranding

1. The firm’s Blueberry Coffee Cake and Carrot Cake 10” products are misbranded because they are fabricated from two or more ingredients and the labels fail to declare the common or usual name of each ingredient, as required. For example:

a. Their Blueberry Coffee Cake:

  i. The labels fail to declare (redacted), an ingredient in their blueberry filling ingredient.

  ii. The label does not bear the statement: “(redacted)” as required.

  iii. The ingredients “Syrus” and “Fondandt” are misspelled, and the flour ingredient “flour unbleached prepared flour” is not an appropriate declaration for a flour ingredient.

b. Their Apple Coffee Cake:

  i. The ingredients “Shortening Hydrogenated Soybean & Cottonseed,” “Flourenhanced” are not the appropriate common or usual names for these ingredients as required. The terms “Artifical,” “USF&D,” “Syrus,” “Fondandt,” “Riboflavor,” and “Propul” are misspelled.

c. Their Carrot Cake 10” label lists cream cheese and its sub-ingredients, which are not used in the product, but fails to list the ingredients in the milk and cheese culture blend that is used in the product. The requirement to list these component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the 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 must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.

d. Their Custard Bundt Cake label lists the ingredient “N&A Flavor,” which is not the appropriate common or usual name of an ingredient, as required.

2. Their Custard Bundt Cakes, Paczki, and Coffee Cakes are misbranded because they do not comply with the requirements. Specifically:

a. Their Custard Bundt Cake:

  i. The serving size is listed as 1 serving (136g). The appropriate Reference Amount Customarily Consumed Per Eating Occasion (RACC) for the product is 80 g/fractional slice for large discrete units in accordance with regulation – Table 2 – Medium weight cakes.

  ii. The serving size is not expressed in common household measures as required.

b. Their Cheese Paczki, Blueberry Coffee Cake, and Apple Coffee Cake labels fail to bear nutrition information; i.e., a Nutrition Facts label, as required. Their firm may qualify for a Small Business Nutrition Labeling Exemption, but as of 6/27/2022, their firm has not filed for the exemption.

3. Their Custard Bundt Cakes are misbranded. Specifically, the label declares the ingredients sodium benzoate and potassium sorbate, which are chemical preservatives and the descriptor of the function of these two ingredients is missing. A food to which a chemical preservative(s) is added must include a separate description of its function, e.g., “preservative”, “to retard spoilage”, “a mold inhibitor”, “to help protect flavor” or “to promote color retention”.