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WARNING LETTER

McClure’s Lancaster Old Fashioned, LLC MARCS-CMS 670611 —


Delivery Method:
VIA UPS
Product:
Food & Beverages

Recipient:
Recipient Name
Mr. Thomas Keenan
Recipient Title
Owner & President
McClure’s Lancaster Old Fashioned, LLC

1212 Reading Road
Bowmansville, PA 17507
United States

Issuing Office:
Division of Human and Animal Food Operations East II

United States


WARNING LETTER
CMS # 670611

May 16, 2024

Dear Mr. Keenan:

The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) bakery products manufacturing facility, located at 1212 Reading Road, Bowmansville, PA, 17507, from September 18 through October 3, 2023. During our inspection of your facility, the FDA found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP and PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117).

Based on FDA’s inspectional findings, we have determined that the RTE sticky buns, pies, and cakes 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 U.S.C. § 342(a)(4)], in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or may have been rendered injurious to health. The inspection also revealed that certain products manufactured in your facility are misbranded because, among other things, the labels for certain products declare the major food allergen of “peanut” as an ingredient which is not intentionally introduced in the formulation of those products, which is false or misleading.1 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 and 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)]. You may find the Act and further information about the CGMP and PC rule through links in FDA's home page at http://www.fda.gov.

On October 3, 2023, at the conclusion of the inspection, the FDA investigators issued your facility a Form FDA 483, Inspectional Observations. To date, we have not received your response to the Form FDA 483. Based on our review of the inspectional findings, we are issuing this letter to advise you of FDA’s continuing concerns and to provide detailed information describing the findings at your facility.

Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C)

1. You 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 your facility to determine whether there are any hazards requiring a preventive control, as required by 21 CFR § 117.130(a)(1). Although you have a written hazard analysis for your RTE creme-filled doughnuts, you told our investigator that you had not conducted a hazard analysis for your various RTE sticky buns, pies, and cakes. Specifically:

a. You 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 your RTE sticky buns, pies, and cakes. For example, your 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 your 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 significantly minimize or prevent the hazards (see 21 CFR § 117.135(c)(1)). Note that these controls must be validated as required by 21 CFR § 117.160.

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

b. You did not identify and evaluate recontamination with environmental pathogens (e.g., Salmonella and L. monocytogenes) as a known or reasonably foreseeable hazard to determine whether recontamination with environmental pathogens is a hazard requiring a preventive control, to comply with 21 CFR § 117.130(c)(1)(ii). Your 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 your 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 (see 21 CFR § 117.135(c)(3)). 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 (see 21 CFR § 117.165(a)(3)).

Your hazard analysis for your doughnut products identifies recontamination with environmental pathogens as a hazard requiring a preventive control. You have an Environmental Monitoring Program (dated June 5, 2023) to verify your sanitation controls; however, you told our investigator that you had not implemented the Environmental Monitoring Program. Also, it is not clear if the areas in your bakery where you manufacture sticky buns, pies, and cakes were included in the program. Furthermore, your 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 by 21 CFR § 117.165(b)(3)(iv), (v), and (vii).

c. You did not identify and evaluate allergens as a known or reasonably foreseeable hazard to determine whether allergens are a hazard requiring a preventive control. Your 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, you 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. You informed our investigator that it was your 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 your 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 (see 21 CFR § 117.135(c)(2)). Note that preventive controls are subject to preventive control management components (monitoring, verification and corrective actions) as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system (see 21 CFR § 117.140).

Current Good Manufacturing Practice (21 CFR Part 117, Subpart B)

2. Your 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 by 21 CFR § 117.40(a)(1). On September 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. You instructed your employees to remove the tape from the exterior areas of the PVC pipe, where 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 your RTE doughnut products, after the fry step. During the inspection, you stated this equipment is only disassembled for cleaning and sanitation (b)(4), which can result in residual creme remaining on the equipment food contact surfaces for several days between production runs.

During the inspection, you stated you would generate written cleaning procedures for the food contact surfaces of the RTE creme-filling equipment. You also indicated that you may consider replacing the PVC piping with stainless steel but did not commit to do so. To date, you have not provided any corrective actions or supporting documentation to demonstrate that you have adequately resolved this observation.

Misbranding Violation:

3. Your Country Maid brand 6- Chocolate Creme Filled Doughnuts and the Country Maid brand 6- Creme Filled Doughnuts are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] 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. You stated that this was done as a mitigation strategy for the identified reasonably foreseeable hazard of “Allergen cross contamination.” However, 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. Your 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 within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] 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 (b)(4) Flour, from the (b)(4), as required by 21 CFR § 101.4(b)(2).
b. Your 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 21 CFR § 101.4.
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 by 21 CFR § 101.4(b)(14).

5. Your 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 within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR § 101.9. 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 defined in 21 CFR § 101.9.
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 you do not appear to have filed for an exemption from the requirement by filing an annual filing for those products which may qualify under 21 CFR § 101.9(j)(18)(ii).

6. Your 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 within the meaning of section 403(k) of the Act [21 U.S.C. § 343(k)], because the products bear or contain chemical preservatives but do not bear labeling stating the function of the preservatives. Specifically:
a. Your 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,” in accordance with 21 CFR § 101.22(j).
b. Your 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. Your 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 within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR § 101.5(a). 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.

This letter is not intended to be an all-inclusive statement of violations that may exist at your facility or 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 and FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

We also offer the following comments:

• We reviewed the regulatory status of the ingredients declared on the labeling of your McClure’s Bakery Lancaster Old Fashioned brand Coconut Cream Pie and McClure’s Bakery Lancaster Old Fashioned brand Chocolate Peanut Butter Streusel products, and the products bear or contain Partially Hydrogenated Oils (PHOs) (i.e., Partially Hydrogenated Palm Kernel oil, Cotton Seed Oil, or Soybean Oil), which, as discussed further below, are unapproved food additives. The regulations pertaining to food additives are located in 21 CFR Part 170.

Any substance intentionally added to a food, such as a bakery product, must be used in accordance with a food additive regulation approving the substance for that use, unless the substance is deemed Generally Recognized as Safe (GRAS) among experts qualified by scientific training and experience to evaluate its safety (“qualified experts”) under the conditions of its intended use, or is otherwise exempt from the food additive definition in section 201(s) of the Act [21 U.S.C. § 321(s)].

PHOs are the primary dietary source of industrially produced trans fatty acids (IP-TFA). On June 17, 2015, FDA issued its final determination that PHOs are no longer GRAS for any use in human food and set a compliance period of three years to allow industry time to either reformulate products without PHOs and/or submit a food additive petition to FDA to permit specific uses of PHOs. The agency established a general compliance date of June 18, 2018, and an extended compliance date of January 1, 2021, for foods manufactured with uses of PHOs for which a food additive petition was submitted before June 18, 2019. All of these compliance dates have now elapsed. Foods bearing or containing PHOs may be subject to enforcement action by FDA. See Final Determination Regarding Partially Hydrogenated Oils (Removing Trans Fat), https://www.fda.gov/food/food-additives-petitions/final-determination-regarding-partially-hydrogenated-oils-removing-trans-fat.

As explained above, the use of PHOs in your McClure’s Bakery Lancaster Old Fashioned brand Coconut Cream Pie and McClure’s Bakery Lancaster Old Fashioned brand Chocolate Peanut Butter Streusel products is not GRAS. Further, FDA is not aware of any other exemption from the food additive definition that would apply to PHOs for use as an ingredient in your bakery products. Therefore, PHOs used in this manner are food additives under section 201(s) of the Act and are subject to the provisions of section 409 of the Act [21 U.S.C. § 348]. Under section 409, food additives are required to be approved by FDA for their intended uses prior to marketing.

• Congress provided for the “Contains” statement as one mechanism to comply with the major food allergen labeling requirements in section 403(w) of the Act [21 U.S.C. § 343(w)]. We note that your McClure’s Bakery Lancaster Old Fashioned brand Coconut Cream Pie label uses a “Contains” statement which includes Yellow #5, which is not a major food allergen.

• Your McClure’s Bakery Lancaster Old Fashioned brand Coconut Cream Pie label lists the ingredient “F,D, & C, Titanium Dioxide.” Titanium Dioxide is not a certified color and therefore FD&C or alternatives to this designation are not part of the common or usual name of the color ingredient, titanium dioxide.

• Your Country Maid brand 6- Chocolate Creme Filled Doughnuts label appears to be missing or contains inappropriately placed commas and/or parentheses. Specifically, the ingredient statement states, in part: “[M]ay contain: soybean, cottonseed and/or palm oil; sugar, cocoa, whole eggs,” etc. It is unclear what part of this statement is intended to be captured by the “may contain” portion of the statement. Fat and/or oil ingredients must be declared in accordance with 21 CFR § 101.4(b)(14).

Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to address the stated violations, including an explanation of each step being taken to identify violations and make corrections to prevent the recurrence of similar violations. In your response, you should include copies of related documentation, including revised procedures, photographs, results of tests you have conducted, and other useful information that would assist us in evaluating your corrections. If you cannot complete corrective actions within fifteen (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, include your reasoning and any supporting information for our consideration.

Your written response should be sent to Compliance Officer Daniel W. Johnson at U.S. Food & Drug Administration, 200 Chestnut St. Room 900 Philadelphia, Pennsylvania 19106. An emailed response is also acceptable. Files greater than 100 megabytes may be submitted as smaller files in separate emails. If you have questions regarding this letter, please contact Daniel W. Johnson by telephone at (215)-717-3746 or by email at Daniel.Johnson@fda.hhs.gov.

Sincerely,
/S/

Robin M. Rivers
Acting Program Division Director
Human & Animal Food East, Division 2
Office of Regulatory Affairs
U.S. Food and Drug Administration
robin.rivers@fda.hhs.gov

_____________________

1 See Section 403(a)(1) of the Act [21 U.S.C § 343(a)(1)].

 
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