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WARNING LETTER

One Roof LLC MARCS-CMS 701988 —

Delivery Method:
United Parcel Service
Product:
Food & Beverages
Recipient:
Recipient Name
Edward C. Atwater
Recipient Title
Owner
One Roof LLC

2905 Whittington Ave
Baltimore, MD 21230
United States

Issuing Office:
Human Foods Program

United States

WARNING LETTER

May 20, 2025

WL #701988

Dear Mr. Atwater:

The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) food manufacturing facility, located at 2905 Whittington Ave, Baltimore, MD, 21230 on October 24, 2024, through December 9, 2024. This inspection was initiated as a follow-up to your voluntary recall of Atwater’s Spider Web Tarts on October 21, 2024, due to undeclared almond in the product. During the inspection, FDA investigators found serious violations 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).

Based on FDA’s inspectional findings, we have determined that your Dark Chocolate Walnut Cookies and Spider Web Tarts 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. 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)]. Further, we found significant violations of the labeling regulation for foods, 21 CFR Part 101. These violations cause your Dark Chocolate Walnut Cookies and Spider Web Tarts to be misbranded within the meaning of section 403 of the Act (21 U.S.C. § 343). You may find the Act and FDA’s regulations through links in FDA’s home page at http://www.fda.gov/.

At the conclusion of the inspection, FDA investigators issued your facility a Form FDA 483, Inspectional Observations. On December 24, 2024, FDA received an email from you describing corrective actions you have taken or plan to take. After reviewing the inspectional findings and your response correspondence, we are issuing this letter to advise you of FDA’s concerns.

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).

Specifically, you provided FDA investigators with a copy of your firm’s HACCP Plans, dated February 15, 2019; however, none of the HACCP Plans covered your Dark Chocolate Walnut Cookies or your Spider Web Tarts. You stated that you were not aware that you are required to have a food safety plan for each type of food manufactured at your facility. As such, you did not conduct a hazard analysis for your Dark Chocolate Walnut Cookies or your Spider Web Tarts.

A. You did not identify and evaluate allergens as a hazard requiring a preventive control. Your facility manufactures bakery products that consist of varying allergen profiles, and these products are processed using shared food-contact equipment and utensils. 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)).

i. Regarding the hazard of allergen cross-contact, we note that on October 29, 2024, investigators observed two employees preparing Dark Chocolate Walnut Cookie dough, which does not contain almonds, by utilizing a shared (b)(4) mixer and shared automated cookie dough machine. Your Food Safety Compliance Officer stated to investigators that the last thing processed using this shared equipment was Almond Shortbread Cookie dough, which contains almond flour, on October 22, 2024. Your Allergen Control Plan, dated September 19, 2024, states “(b)(4).” However, on October 29, 2024, prior to the mixer being utilized to make Dark Chocolate Walnut Cookie dough, investigators observed white and brown substances on the mixer shaft and on the interior surface of the mixer bowl, despite the cleaning that the mixer underwent after the production of Almond Shortbread Cookie dough the week before. The investigators observed an employee tilting the mixer to discharge the Dark Chocolate Walnut Cookie dough into plastic bins, causing the dough to come into contact with the white and brown substances at the base of the mixer shaft.

ii. We also note, regarding the hazard of undeclared allergens, your Allergen Control Plan states, “(b)(4).” However, the plan does not include procedures, practices, or processes to control for undeclared allergens (or for monitoring or verifying these controls) to ensure that finished food is not misbranded under section 403(w) of the Act, such as checking the content of a label for accuracy and ensuring the correct label is applied to the product being packaged and labeled. On October 21, 2024, you recalled your Atwater’s Spider Web Tarts, Julian date 292, after discovering that the product label did not declare tree nuts (almond), despite almond flour being included as a product ingredient.

B. You did not identify and evaluate recontamination with environmental pathogens 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, such as Dark Chocolate Walnut Cookies and Spider Web Tarts, that are exposed to the environment after they exit the oven (during cooling, consolidating, and packaging). The packaged foods do not receive any further lethal treatment or otherwise include a control measure that would significantly minimize the pathogen. Contamination with environmental pathogens is a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in your circumstances would identify contamination with environmental pathogens as a hazard requiring a preventive control. Preventive controls include sanitation controls, which 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)).

i. 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). However, FDA investigators observed several instances where you did not record monitoring of sanitation activities at the frequency for which they should occur. Specifically, your automated dishwashing machine is used to wash plastic and stainless-steel food-contact equipment and utensils that are used (b)(4) step ((b)(4)) to prepare and/or store Dark Chocolate Walnut Cookies and Spider Web Tarts, including trays, whisks, and bowls. Your Dish Machine SSOP, dated October 19, 2021, indicates that you will check the “(b)(4)” at a frequency of “(b)(4).” However, a review of your (b)(4) DISH MACHINE records from January 2, 2024 through October 25, 2024, revealed missing records for the following dates: January 10-15, 2024, January 21-22, 2024, January 26, 2024, January 28-31, 2024, February 3-26, 2024, March 5 – April 22, 2024, April 28-29, 2024, May 3, 2024, May 5-7, 2024, May 13, 2024, May 15-16, 2024, May 19-21, 2024, May 26-28, 2024, June 2 – October 14, 2024, and October 19-21, 2024. You were unable to provide an explanation for the gaps in recordkeeping.

ii. 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)). Note that if environmental monitoring is required, an environmental monitoring written procedure must be established and implemented and must meet the requirements in 21 CFR § 117.165(b)(3). During our review of your environmental monitoring records from July 24 through August 28, 2024, we found that two (2) swabs collected on July 24, 2024 were found to be presumptive positive for Listeria spp.; one (1) swab collected from the “(b)(4)” and another swab collected from the “(b)(4).” A “(b)(4)” vector swab collected on July 31, 2024 was found to be presumptive positive for Listeria spp.; three (3) additional “(b)(4)” vector swabs collected on August 14, 2024 were found to be presumptive positive for Listeria spp.; and one (1) additional “(b)(4)” vector swab collected on August 28, 2024 was found to be presumptive positive for Listeria spp. However, your Environmental Monitoring Program, dated October 24, 2024, does not indicate what steps you must take after receiving a presumptive positive result for pathogens.

You stated when you receive a presumptive positive result for environmental pathogens, you clean the area, re-swab the location of the positive finding, and collect vectors. However, you did not document these actions for the above-described results. Additionally, you were not able to explain how food, if affected, was evaluated for safety. Note that corrective action procedures must describe the steps to be taken to ensure, among other things, that appropriate action is taken, when necessary, to reduce the likelihood that the problem will recur, and all affected food is evaluated for safety (21 CFR 117.150(a)(2)(ii) and (iii)).

iii. FDA environmental sample #(b)(4) was collected from your facility on November 6, 2024 and non-pathogenic Listeria innocua was isolated from five (5) out of 68 swabs. These positive swabs were found in areas in or adjacent to where RTE products are processed. The presence of a non-pathogenic Listeria species indicates that conditions suitable for the survival and/or growth of the pathogen Listeria monocytogenes exist within your facility.

C. You did not identify and evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control. Your facility manufactures RTE bakery products, such as Dark Chocolate Walnut Cookies and Spider Web Tarts, which contain ingredients such as tree nuts (e.g., walnuts and almonds) and/or chocolate for baking; these ingredients have been associated with mycotoxins. Contamination with mycotoxins is a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in your circumstances would identify mycotoxins as a hazard requiring a preventive control (i.e., a supply-chain control) in these ingredients. Further, a facility that identifies raw materials and other ingredients that require a supply-chain-applied control due to a hazard such as mycotoxins, must establish and implement a risk-based supply-chain program for those raw materials and 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).

Your Supplier Approval Program, dated August 29, 2024, indicates that management is responsible for obtaining supporting documentation from potential suppliers, such as “(b)(4).” However, you were not able to provide any documentation to support your approval of your suppliers of walnuts, almond flour and chocolate.

D. You did not identify and evaluate metal as a known or reasonably foreseeable hazard to determine whether it requires a preventive control. On October 29, 2024, investigators observed employees utilizing the dough mixer and cookie dough machine (dough divider) while manufacturing Dark Chocolate Walnut Cookie dough; they observed that the edge of the auger that comes into contact with the metal wall of the cookie dough machine was nicked. A knowledgeable person manufacturing/processing food in your circumstances would identify metal as a hazard requiring a preventive control.

You do not have any process controls in place to ensure the exclusion of metal such as physical separation techniques (e.g., magnets, sieves, screens, or flotation tanks), use of metal detection devices, and regular inspections of at-risk equipment for signs of damage.

We received your 483 response, dated December 24, 2024, and provide the following comments:

o In your response, you included a Hazard Analysis for your Dark Chocolate Walnut Cookies, and you stated that you are “creating a hazard analysis” for each of your cookies. We have not yet received a hazard analysis for your Spider Web Tarts. We remind you that 21 CFR 117.130 and 117.126 require firms to conduct a hazard analysis for each type of food manufactured, processed, packed, or held at your facility, and to incorporate these hazard analyses into a broader food safety plan. We will verify the adequacy of your corrective actions during a future inspection of your facility.

o Regarding allergen cross-contact, you stated that on December 18, 2024, employees were trained throughout the entire cookie dough process. During the training, you inspected the condition and cleanliness of equipment prior to the start of production, as well as after post-production cleaning to ensure there is no remaining residue on the equipment that would pose the hazard of allergen cross-contact. You implemented an Atwater’s Equipment Pre- and Post-Production Checklist to conduct “(b)(4)” and you submitted two (2) copies of checklists completed on December 18, 2024. We will verify the adequacy of your corrective actions during a future inspection of your facility.

o Regarding undeclared allergens, you stated you created a Recipe, Label, and Allergen Verification Log, intended for employees to use prior to rolling out new and seasonal products. The baker will record on the log what ingredients they used in a new recipe, and the label designer will use the log to verify that the product label accurately reflects the product ingredients. You attached a copy of a completed log for Cran Orange Muffins as an example, and you stated you are creating procedures to ensure employees understand how to use this log. While we acknowledge the steps you have taken to mitigate the risk of undeclared allergens in new and seasonal products, you should also be monitoring that the correct label is applied to these products, and the label is accurate, with adequate frequency to ensure that the products consistently do not contain undeclared allergens. Lastly, 21 CFR § 117.135(c)(2) requires these controls to be employed for all finished food products, rather than only new or seasonal food products.

o Regarding recontamination with environmental pathogens, your Hazard Analysis for Dark Chocolate Walnut Cookies states, “(b)(4).” However, you did not identify recontamination with environmental pathogens as a potential hazard at any other steps, such as (b)(4). For control measures, your Hazard Analysis lists, “(b)(4).” However, preventive controls must include sanitation controls, which 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. You also stated that you will be training additional employees on how to fill out monitoring records, such as your (b)(4) DISH MACHINE records, so that no records are missed. We will verify the adequacy of your corrective actions during a future inspection of your facility.

o Regarding mycotoxins, you stated that you are in the process of gathering documentation for approval of all your suppliers. In the meantime, you submitted a questionnaire completed by one of your suppliers, as well as a COA for milk as part of your response. However, we are unable to fully assess the adequacy of your corrective actions because you did not submit documentation pertaining to the approval of your suppliers of walnuts, almond flour, or chocolate. Additionally, you have not identified ongoing supplier verification activities, such as sampling and testing, that you will conduct to ensure mycotoxins are being controlled by your supplier for future shipments of walnuts, almond flour, and chocolate. We will verify the adequacy of your corrective actions during a future inspection of your facility.

o Regarding metals, you stated you will be repairing or replacing the dented/damaged auger of the cookie dough machine (dough divider). Your production manager will be contacting the company you got the machine from to start the replacement process. Additionally, the Hazard Analysis you submitted for your Dark Chocolate Walnut Cookies indicates the production team will inspect for metal fragments and damage during pre- and post-production equipment checks. We will verify the adequacy of your corrective actions during a future inspection of your facility.

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

1. You did not clean and sanitize your utensils or equipment in a manner that protects against allergen cross-contact and against contamination of food, food-contact surfaces, or food-packaging materials, as required by 21 CFR 117.35(a). Specifically, during the inspection, investigators observed the following:

A. On October 29, 2024, investigators observed an employee cleaning and sanitizing the mixer and cookie dough machine (dough divider) following the production of Dark Chocolate Walnut Cookie dough. The employee scrubbed the machines to remove dough residue, applied soap, applied (b)(4) Sanitizer, and left the equipment to air dry. Investigators used quaternary test strips, with an expiration date of April 2025, to test the concentration of the (b)(4) Sanitizer solution prepared by the employee, and found the concentration fell below (b)(4) ppm. However, the labeling for the (b)(4) Sanitizer indicates the concentration should fall between (b)(4) ppm to be effective.

B. On October 24, 2024, investigators observed an employee cleaning plastic and stainless-steel food contact equipment and utensils, used to prepare RTE foods, such as cookies including Spider Web Tarts, by rinsing them, placing them in a basket, and putting them through a (b)(4) dishwasher. The employee then gathered dirty equipment and utensils, and returned to retrieve the cleaned items which were stored on a shelf to air dry, without washing their hands or changing their gloves at any point during the process.

In your December 24, 2024 response, you stated that starting November 4, 2024, all employees are verifying that every bucket of sanitizer solution falls within the correct concentration range and that these checks are being recorded on a zoning/sanitizer log. You attached copies of several completed logs as an example. You stated all employees will receive a refresher training on red and green buckets for cleaning and sanitizing, allergen awareness, glove use/handwashing, and “(b)(4)” by January 31, 2024. We will verify the adequacy of your corrective actions during a future inspection of your facility.

Misbranding Violations

1. Your GLUTEN-FREE ATWATER’S TRADITIONAL FOOD CHOCOLATE CHIP, ATWATER’S TRADITIONAL FOOD ALMOND SHORTBREAD, ATWATER’S TRADITIONAL FOOD DARK CHOCOLATE WALNUT, ATWATER’S TRADITIONAL FOOD GINGERDOODLE, and ATWATER’S SPRINKLE DOODLES products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information (e.g. Nutrition Facts Panel) is not in a correct format, as required by 21 CFR 101.9. Specifically:

a. Your ATWATER’S SPRINKLE DOODLES product fails to bear any nutritional information (e.g., Nutrition Facts label), as required by 21 CFR 101.9.
b. For your GLUTEN-FREE ATWATER’S TRADITIONAL FOOD CHOCOLATE CHIP, ATWATER’S TRADITIONAL FOOD ALMOND SHORTBREAD, ATWATER’S TRADITIONAL FOOD DARK CHOCOLATE WALNUT, and ATWATER’S TRADITIONAL FOOD GINGERDOODLE products:

  • The Nutrition Facts Label (NFL) does not meet the requirements in section 21 CFR 101.9. For example, it is missing required nutrients, including “Added Sugars”, and required vitamins and minerals, in accordance with 21 CFR 101.9(c) and does not meet the format requirements in 21 CFR 101.9(d).

2. Your ATWATER’S SPIDER WEB TART, ATWATER’S SPRINKLE DOODLES, and ATWATER’S TRADITIONAL FOOD DARK CHOCOLATE WALNUT products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product labels fail to declare all the common or usual names of each ingredient used, as required by 21 CFR 101.4. Specifically:

  a. Your ATWATER’S TRADITIONAL FOOD DARK CHOCOLATE WALNUT ingredient list includes the term “Cocoa mass,” which is not an appropriate common or usual name for an ingredient.

3. Your ATWATER’S SPRINKLE DOODLES product is misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. 343(e)(2)] in that the label fails to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count, as required by 21 CFR 101.7.

In your December 24, 2024 response, you stated that your Sprinkle Doodles are a seasonal product. You will correct the misbranding issues by the fall of 2025, when the production of Sprinkle Doodles resumes. We will verify the adequacy of your corrective actions during a future inspection of your facility.

Lastly, we offer the following comment:

  We note that when a Contains statement is used to declare the food sources of the major food allergens that are ingredients in the food, section 403(w) of the FD&C Act requires that the specific type of tree nut be declared (e.g., almonds, pecans, walnuts). This means that the “Contains” statement cannot broadly declare “tree nuts.”

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 adequately address this matter may result in legal action including, without limitation, seizure, and injunction.

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, include your reasoning and any supporting information for our consideration.

Your written response should be sent electronically to: HFP-OCE-ConventionalFoods@fda.hhs.gov, copying Clarice J. Ahn, Compliance Officer, at Clarice.Ahn@fda.hhs.gov. Please include “CMS 701988,” in all correspondence. If you have questions regarding this letter, please contact Clarice J. Ahn, Compliance Officer at clarice.ahn@fda.hhs.gov.

Sincerely,
/S/

Maria S. Knirk, JD, MBA
Acting Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program

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