The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. 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.

Bimbo Bakeries USA Inc.
Horsham, PA

The FDA has warned a food firm in Pennsylvania after an inspection found serious violations of the Federal Food, Drug, and Cosmetic Act, including misbranded products that are false or misleading.

In a June 17, 2024, warning letter, the FDA described an October 3-27, 2023, inspection of Bimbo Bakeries USA, Inc.’s facility in Phoenix, AZ. The FDA also commissioned the Kansas Department of Agriculture employees to inspect the firm’s facility in Topeka, KS.

based on the inspectional findings and review of the firm’s product labels, the FDA has identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations.

Some of the violations:

1. The firm’s Sara Lee brand Artesano Brioche, Delightful Multigrain, Artesano Golden Wheat, and Artesano Smooth Multigrain ready-to-eat (RTE) bread loaf products are misbranded in that the product labels are false or misleading because they include sesame seeds in the ingredient and “Contains” statements; however, sesame seed is not an ingredient in the product formulations. The Brownberry brand Whole Grains 12 Grains and Seeds RTE bread loaf product is misbranded for a similar reason; the product label includes walnuts, almonds, and hazelnuts in the ingredient and “Contains” statements; however, these nuts are not ingredients in the formulation of the product. FDA expects food manufacturers to follow good manufacturing practices and implement preventive controls to prevent the unintentional incorporation of allergens into foods which are not formulated to contain them. Labeling is not a substitute for adherence to good manufacturing practices or implementation of preventive controls. Instead, firms must comply with applicable requirements to address allergen cross-contact.
2. The firm’s Brownberry brand Whole Grains 12 Grains and Seeds product is misbranded in that:
    a. They use (redacted by FDA) for (redacted by FDA), (redacted by FDA) as (redacted by FDA), and (redacted by FDA) for (redacted by FDA), but do not list these ingredients on the product label.
    b. The ingredient list declares “Kamut®” which is not part of the common or usual name of Khorasan wheat because it is a brand name. Furthermore, Khorasan is misspelled as “Khorsan.”

The full warning letter can be viewed here.

McClure’s Lancaster Old Fashioned LLC
Bowmansville, PA

The FDA has warned a food firm in Pennsylvania after an inspection found serious violations of the Hazard Analysis and Risk-based Preventive Controls and Current Good Manufacturing Practice regulations, including not conducting a hazard analysis for their various ready-to-eat (RTE) sticky buns, pies and cakes.

In a May 16, 2024, warning letter, the FDA described a Sept. 18 through Oct. 3, 2023, inspection of McClure’s Lancaster Old Fashioned, LLC’s ready-to-eat (RTE) bakery products manufacturing facility in Bowmansville, PA. 

The FDA’s inspection revealed that the firm was not in compliance with federal regulations, which resulted in the issuance of an FDA Form 483. 

Some of the significant violations are as follows:

Hazard Analysis and Risk-based Preventive Controls

1. The firm did not conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at their facility to determine whether there are any hazards requiring a preventive control, as required. Although they have a written hazard analysis for their RTE creme-filled doughnuts, they told FDA investigators that they had not conducted a hazard analysis for their various RTE sticky buns, pies, and cakes. Specifically:

a. The firm did not identify and evaluate bacterial pathogens, such as Salmonella, as a known or reasonably foreseeable hazard to determine whether bacterial pathogens are a hazard requiring a preventive control in their RTE sticky buns, pies, and cakes. For example, their facility manufactures RTE banana cream pie and chocolate peanut butter streusel, which contain eggs and wheat flour as ingredients. These ingredients have been associated with vegetative bacterial pathogens, such as Salmonella and pathogenic E. coli.

A knowledgeable person manufacturing/processing food in their circumstances would identify bacterial pathogens as a hazard requiring a preventive control. Preventive controls include process controls, which include procedures, practices, and processes to ensure the control of parameters during operations such as heat processing. Process controls must also include the parameters associated with the control of the hazard and the minimum and/or maximum values needed to minimize or prevent the hazards significantly. Note that these controls must be validated as required.

During the inspection, the firm told FDA investigators that they would conduct a hazard analysis for their sticky buns, pies, and cakes, as many of the hazards and mitigation strategies will be similar to those they identified for their creme-filled doughnuts. However, to date, they have not provided the hazard analysis for sticky buns, pies, and cakes.

b. The firm did not identify and evaluate recontamination with environmental pathogens (e.g., Salmonella and Listeria monocytogenes) as a known or reasonably foreseeable hazard to determine whether recontamination with environmental pathogens is a hazard requiring a preventive control. Their facility manufactures RTE bakery products (sticky buns, pies, and cakes) which are exposed to the environment after cooking, such as while they are cooled and prior to packaging. The packaged food does not receive any further lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen.

A knowledgeable person manufacturing/processing food in their circumstances would identify contamination with environmental pathogens as a hazard requiring a preventive control. For example, 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. In addition, note that environmental monitoring is required if contamination of an RTE food with an environmental pathogen is a hazard requiring a preventive control.

Their hazard analysis for their doughnut products identifies recontamination with environmental pathogens as a hazard requiring a preventive control. They have an Environmental Monitoring Program (dated June 5, 2023) to verify their sanitation controls; however, they told FDA investigators that they had not implemented the Environmental Monitoring Program. Also, it is not clear if the areas in their bakery wher they manufacture sticky buns, pies, and cakes were included in the program. Furthermore, their Environmental Monitoring Program does not identify the timing and frequency for collecting and testing the samples, identify the analytical tests to be conducted, or include the corrective action procedures, as required.

c. The firm did not identify and evaluate allergens as a known or reasonably foreseeable hazard to determine whether allergens are a hazard requiring a preventive control. Their facility manufactures various bakery products (sticky buns, pies, and cakes) that contain allergens (such as wheat, eggs, milk, soy, peanut, and tree nuts), and products containing different allergen profiles are processed on shared equipment and using shared utensils on the same production day. For example, they manufacture a banana cream pie (that contains wheat, eggs, milk, and soy) and a coconut cream pie (that contains wheat, eggs, milk, soy, and coconut) in the same area of the facility using the same equipment. They informed FDA investigators that it was their regular practice to produce products that contain different allergen profiles using shared utensils and equipment on the same production day.

A knowledgeable person manufacturing/processing food in their circumstances would identify allergens as a hazard requiring a preventive control. Food allergen controls include procedures, practices, and processes employed for ensuring protection of food from allergen cross-contact (including during storage, handling, and use) and for labeling to ensure that all food allergens required to be stated are included on the label.

Current Good Manufacturing Practice

2. The firm’s equipment and utensils were not designed and were not of such material and workmanship to be adequately cleanable, and were not adequately maintained to protect against contamination, as required. On Sept. 20, 2023, the FDA Investigator observed production of Country Maid Creme Filled Doughnuts with Lot Code: 263 and noted duct tape at the joints of the grey PVC pipe which appeared uncleanable and was located directly above exposed creme inside the doughnut filler-hopper. They instructed their employees to remove the tape from the exterior areas of the PVC pipe, wher our investigator observed numerous gouges which do not appear easily cleanable. This equipment is used to convey ready-to-eat creme to the filler-hoppers, which inject creme into their RTE doughnut products, after the fry step. During the inspection, they stated this equipment is only disassembled for cleaning and sanitation (redacted by FDA), which can result in residual creme remaining on the equipment food contact surfaces for several days between production runs.

Misbranding Violation:

3. The firm’s Country Maid brand 6- Chocolate Creme Filled Doughnuts and the Country Maid brand 6- Creme Filled Doughnuts are misbranded in that the labeling is false or misleading because “peanut” is declared in the “Contains” statements; however, “peanut” is not an ingredient in the formulations of these products. They stated that this was done as a mitigation strategy for the identified reasonably foreseeable hazard of “Allergen cross contamination.” However, the FDA expects food manufacturers to follow the CGMP and PC rule to prevent the unintentional incorporation of allergens into foods which are not formulated to contain them. Labeling is not a substitute for adherence to the CGMP and PC rule. Instead, firms must comply with the applicable CGMP and PC requirements to address allergen cross-contact.

4. The firm’s Country Maid brand 6- Creme Filled Doughnuts, Country Maid brand 6- Chocolate Creme Filled Doughnuts and McClure’s Bakery Lancaster Old Fashioned brand Coconut Cream Pie products are misbranded in that:
a. The Country Maid brand 6- Creme Filled Doughnuts and Country Maid brand 6- Chocolate Creme Filled Doughnuts product ingredient labels fail to declare the appropriate common or usual name and the sub ingredients of the (redacted by FDA) Flour, from the (redacted by FDA), as required.
b. The firm’s Country Maid brand 6- Chocolate Creme Filled Doughnuts ingredient listing states, in part: “[M]ay contain: soybean, cottonseed and/or palm oil; sugar, cocoa, whole eggs,” etc. which is not in accordance with regulation.
c. The McClure’s Bakery Lancaster Old Fashioned brand Coconut Cream Pie ingredient label declares “shortening (soy & palm)” but does not include the term “vegetable” preceding “shortening,” as required.

5. The firm’s McClure’s Bakery Lancaster Old Fashioned brand Coconut Cream Pie, Country Maid brand 6- Chocolate Creme Filled Doughnuts and Country Maid brand 6- Creme Filled Doughnuts products are misbranded in that the nutrition facts information is not as defined in regulation.

Specifically,
a. The Nutrition Facts label (NFL) on the McClure’s Bakery Lancaster Old Fashioned brand Coconut Cream Pie product does not use the correct format.
b. The Country Maid brand 6- Chocolate Creme Filled Doughnuts and the Country Maid brand 6- Creme Filled Doughnuts products do not include an NFL and they do not appear to have filed for an exemption from the requirement by filing an annual filing for those products which may qualify.

6. The firm’s McClure’s Bakery Lancaster Old Fashioned brand Coconut Cream Pie, Country Maid brand 6- Creme Filled Doughnuts and the Country Maid brand 6- Chocolate Creme Filled McClure’s Lancaster Old Fashioned, LLC. dba TNT Bakery FEI: 3004388201 CMS: 670611 Page 5 of 7 pages

Doughnuts products are misbranded because the products bear or contain chemical preservatives but do not bear labeling stating the function of the preservatives. Specifically:
a. The firm’s McClure’s Bakery Lancaster Old Fashioned brand Coconut Cream Pie product contains the chemical preservatives potassium sorbate and TBHQ; however, the product fails to bear labeling stating a separate description of the preservative functions, e.g., “preservative,” “to retard spoilage,” “a mold inhibitor,” “to help protect flavor” or “to promote color retention.”
b. The firm’s Country Maid brand 6- Creme Filled Doughnuts and the Country Maid brand 6- Chocolate Creme Filled Doughnuts products contain the preservatives calcium propionate and sodium propionate in the ingredient lists; however, the preservative functions are not declared.

7. The firm’s McClure’s Bakery Lancaster Old Fashioned brand Coconut Cream Pie, Country Maid brand 6- Creme Filled Doughnuts and the Country Maid brand 6- Chocolate Creme Filled Doughnuts products are misbranded in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required. 

Specifically, the McClure’s Bakery Lancaster Old Fashioned brand Coconut Cream Pie fails to list the street address, city, state, and ZIP code and the Country Maid brand 6- Creme Filled Doughnuts and the Country Maid brand 6- Chocolate Creme Filled Doughnuts fail to list the street address; however, the street address may be omitted if the firm is listed in the local city or telephone directory.

The full warning letter can be viewed here.