- Delivery Method:
- VIA EMAIL WITH READ RECEIPT
- Food & Beverages
Recipient NameAnthanasios Kailis
- Third Synthesis Inc., dba Chicago Sweet Connections, Inc.
5569 N. Northwest Highway
Chicago, IL 60630
- Issuing Office:
- Division of Human and Animal Food Operations East VI
FY22-HAFE6-WL-06 CMS 633453
September 6, 2022
Dear Mr. Kailis:
The United States Food and Drug Administration (FDA) inspected your bakery facility located at 5569 N. Northwest Highway, Chicago, IL from February 24, 2022 through March 24, 2022, and on May 3, 2022, FDA investigators returned to your facility to collect further documentation and product labeling. During the inspection, FDA investigators found serious violations, described below, of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). At the conclusion of the inspection, FDA issued an FDA Form 483, Inspectional Observations, listing violations found at your facility.
Based on FDA’s inspectional findings, we have determined that the ready-to-eat (RTE) cakes and paczkis manufactured in your facility are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Codes (U.S.C.) § 342(a)(4)] because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in Subparts A, C, D, E, F, and G of Part 117) is prohibited by Section 301(uu) of the Act [21 U.S.C. § 331(uu)].
Additionally, we reviewed product labels collected during our inspection. Based on our review, we concluded that certain products are in violation of section 403 of the Act [21 U.S.C. § 343], as described further in this letter. You can find the Act and FDA’s regulations through internet links in FDA's website at http://www.fda.gov.
During the course of the inspection, 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 your firm on February 25, 2022.
We received your written response dated April 13, 2022, which included a summary of corrective actions by your facility. After reviewing the inspectional findings and your response to the observations listed in the FDA Form 483, we are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility. We address your response below.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):
1. You did not appropriately evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control for your RTE cakes and paczkis, as required by 21 CFR 117.130(a)(1). Specifically:
a. Your 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, your 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 your 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 (see 21 CFR 117.135(c)(2)(ii)).
We note that you had an allergen control program, “Allergen Control Program No: CSCB-208." However, you did not have adequate allergen controls in place as evidenced by your February 25, 2022 recall of paczkis and coffee cakes which did not declare allergens including wheat, milk and/or egg. Further, your allergen control program did not adequately address the monitoring of labels. The program stated that “(b)(4).” 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 (see 21 CFR 117.145(a)). Additionally, you 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 your firm on February 25, 2022.Your response stated that fresh finished product bakery item labels will be reviewed on a (b)(4) basis and that QA is not always available to check the variety of products that are being packed and labeled. However, a (b)(4) review of labels is not adequate to ensure that allergens are correctly declared on your product labels and that the right label is applied during production.
b. Your 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 your “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 your Sanitation SOP referenced above (see 21 CFR 117.135(c)(2)(i)). Thus, we 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, your hazard analysis did not consider allergen cross-contact at the cake slicing and finishing/icing steps. You manufacture 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 your circumstances would identify allergen cross-contact as a hazard requiring a preventive control.
We note that although you had an allergen control program, it did not adequately address cross contact. Your program stated that “(b)(4).” 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 (b)(4), 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 (b)(4) to an adjacent prep table where the cream cheese frosting was smoothed using a flat, long spatula. The employees also added additional cream cheese frosting as needed from a (b)(4) on the table, using the spatula. On the same day, immediately after frosting your 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 (b)(4) that had been used for the Carrot Cake.
Your response stated that you are now running any products that contain allergens last in your production schedule. However, your response did not provide an updated production schedule, batch record, or monitoring records to demonstrate implementation. Also, your response did not elaborate how you sequence allergen-containing products with different allergen profiles (e.g., sequencing among products with various unique tree nut allergens). Finally, your response did not provide details of when and how cleaning of food-contact equipment will be performed between products with different allergen profiles.
c. Your hazard analysis considered pathogen contamination via equipment and workers at the cooling/depanning, cake slicing, (b)(4), setup, 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 (see 21 CFR 117.135(c)(3)). Thus, we 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, your hazard analysis did not consider pathogen contamination at the finishing/icing step. Your 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 (such as a formulation lethal to the pathogen) 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 your circumstances would identify environmental pathogens as a hazard requiring a preventive control (i.e., sanitation controls).
We note that although your sanitation SOP included environmental monitoring, you did not implement this aspect of the SOP. Specifically, your SOP stated that “QA member will conduct environmental swab[bing] [for] Listeria and Salmonella  (b)(4).” During the inspection, your Director of Operations stated that the facility does not collect environmental swabs for Listeria, Salmonella, or any target organism.
Your response stated that you updated your sanitation SOP to include performing environmental monitoring (b)(4). However, you did not provide the updated sanitation procedure or documentation to show that you are collecting environmental samples at your facility. We have reached out to you requesting supporting documentation and have not received a response to date.
d. Your hazard analysis did not identify and evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control. Your 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 your circumstances would identify mycotoxins as a hazard in ingredients that requires a supply-chain-applied control (i.e., the hazard is associated with an ingredient and is controlled before receipt of the ingredient) and would establish and implement a risk-based supply-chain program for those raw materials and other ingredients (see 21 CFR § 117.405(a)(1)). The supply-chain program must include using approved suppliers and conducting supplier verification activities (see 21 CFR § 117.410). We note that you had a receiving procedure, “Receiving Raw Materials Document No: SOP-101," but it did not address the use of approved suppliers (see 21 CFR 117.415(a)(1)), and you did not approve suppliers.
Your response stated that you have included mycotoxins in your hazard analysis, that your suppliers will include mycotoxins as part of the COAs they send to you, and if their COAs do not include mycotoxin results, they will send you a letter of guarantee (b)(4). However, you did not provide an updated hazard analysis, receiving procedure, or implementation records. Also, note that an (b)(4) guarantee alone would not be an adequate verification activity to ensure that a supplier is controlling the hazard of mycotoxins because it does not include, among other things, actual analytical results from sampling and testing.
Current Good Manufacturing Practice (21 CFR Part 117, Subpart B):
2. You did not store or transport food, including ingredients, under conditions that protect against allergen cross-contact to comply with 21 CFR 117.93. 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 (b)(4) 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 (b)(4) tall, on a rolling speed rack. Each topping had a loose piece of parchment paper placed on top 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.
Your response stated that you have a dedicated rolling rack for allergens and that cakes that contain allergens must be fully packaged upon completion; however, you have not provided any documentation that these corrective actions have been implemented. We have reached out to you requesting supporting documentation and have not received a response to date.
1. Your Blueberry Coffee Cake and Carrot Cake 10” products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] 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 under 21 CFR 101.4. For example:
a. Your Blueberry Coffee Cake:
i. The labels fail to declare (b)(4), an ingredient in your blueberry filling ingredient.
ii. The label does not bear the statement: “(b)(4)” as required by 21 CFR 172.804(d)(2).
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. Your Apple Coffee Cake:
i. The ingredients “Shortening Hydrogenated Soybean & Cottonseed,” “Flourenhanced” are not the appropriate common or usual names for these ingredients as required under 21 CFR 101.4(a). The terms “Artifical,” “USF&D,” “Syrus,” “Fondandt,” “Riboflavor,” and “Propul” are misspelled.
c. Your Carrot Cake 10” label lists cream cheese and its subingredients, which is 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. Your Custard Bundt Cake label lists the ingredient “N&A Flavor,” which is not the appropriate common or usual name of an ingredient, as required by 21 CFR 101.4(a).
2. Your Custard Bundt Cakes, Paczki, and Coffee Cakes are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] because they do not comply with the requirements in 21 CFR 101.9. Specifically:
a. Your 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 21 CFR 101.12(b) – Table 2 – Medium weight cakes.
ii. The serving size is not expressed in common household measures as required by 21 CFR 101.9(b)(7).
b. Your Cheese Paczki, Blueberry Coffee Cake, and Apple Coffee Cake labels fail to bear nutrition information; i.e., a Nutrition Facts label, as required by 21 CFR 101.9(a). Your firm may qualify for a Small Business Nutrition Labeling Exemption, but as of 6/27/2022, your firm has not filed for the exemption.
3. Your Custard Bundt Cakes are misbranded within the meaning of section 403(k) of the Act [21 U.S.C. §343(k)]. Specifically, the label declares the ingredients sodium benzoate and potassium sorbate, which are chemical preservatives in accordance with 21 CFR 184.1733 and 182.3640, respectively, and the descriptor of the function of these two ingredients is missing. In accordance with 21 CFR 101.22(j), 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”.
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to do so may result in legal action including, without limitation, seizure and injunction.
We also offer the following comment for your Custard Bundt cake label: we note that as a fabricated food, most sugars would not be considered naturally occurring; almost all sugars would be added sugars.
In your Ingredient statement the first ingredient is sugar, and the Nutrition Facts Label’s added sugar declaration states “37g Total Sugars” but “< 1g Added Sugars.” Information about food labeling, including nutrition labeling and nutrition labeling exemptions, can be found at the following link: https://www.fda.gov/food/food-labeling-nutrition.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act or that you have complied with FDA regulations, include your reasoning and any supporting information for our consideration.
Your reply should be addressed to the U.S. Food and Drug Administration; Attn: Lauren Crivellone, Compliance Officer, via email at ORAHAFEAST6FirmResponses@fda.hhs.gov or at 550 West Jackson Boulevard, Chicago, IL 60661. You may reach Ms. Crivellone at 312-206-5264 or via email at Lauren.Crivellone @fda.hhs.gov if you have any questions about this matter.
William R. Weissinger, MS
Program Division Director
Office of Human and Animal Food Operations
Division East 6