WARNING LETTER
Knickerbocker 365 Inc.
MARCS-CMS 687624 —
September 30, 2024
Delivery Method:
VIA EMAIL WITH READ RECEIPT: NO HARD COPY TO FOLLOW
Product:
Food & Beverages
Recipient:
Recipient Name
Sandra T. Sokana
Recipient Title
President/Owner
Knickerbocker 365 Inc.
26040 Pinehurst Dr.
Madison Heights
,
MI
48071
United States
(b)(6)
Issuing Office:
Office of Human & Animal Food Operations East 6
550 W. Jackson Blvd 300 River Place Drive Suite 800
Chicago
,
IL
60661
United States
(312) 353-5863
WARNING LETTER
Reference # 687264
Dear Ms. Sokana:
The U.S. Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) breads, rolls, and buns manufacturing facility located at 26040 Pinehurst Dr., Madison Heights, MI 48071 from April 29, 2024 through May 31, 2024. During our 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 the RTE breads, rolls, and buns processed 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 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)]. You may find the Act and further information about the CGMP & PC rule through links in FDA's internet home page at www.fda.gov.
At the conclusion of the inspection, FDA investigators issued an FDA Form 483, Inspectional Observations. You provided responses to the inspection on June 17, 2024 and June 19, 2024, describing corrective actions taken or planned by your firm. After reviewing the inspectional findings and the responses that your firm provided, 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 responses below.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR 117, Subpart C):
1.    Your hazard analysis did not identify and evaluate a known or reasonably foreseeable hazard to determine whether it requires a preventive control, as required by 21 CFR 117.130(a)(1). Specifically, your hazard analysis, “21.0 HACCP Last Revision 3/2024”, for RTE breads, rolls, and buns did not consider recontamination with environmental pathogens, such as
Salmonella
, at steps where your RTE breads, rolls, and buns are exposed to the environment. Your RTE breads, rolls, and buns are exposed to the environment at post-baking steps (including “Cooling,” “De-panning,” “Slicing,” and “Packaging”) where they could be contaminated with environmental pathogens such as
Salmonella
, and do not receive a lethal treatment or otherwise include a control measure (such as 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 recontamination with environmental pathogens as a hazard requiring a preventive control (i.e., sanitation control). Sanitation preventive 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 (see 21 CFR 117.135 (c)(3)).
Your RTE breads, rolls, and buns come into direct contact with post-baking equipment, such as the “
(b)(4)
slicer” “the
(b)(4)
Slicer,” and the “
(b)(4)
Slicer.” However, we note that your written sanitation procedures, documented on the “
(b)(4)
Cleaning Checklist,” for equipment used post-baking do not indicate sanitizer concentration or how to clean utensils and clean out-of-place (COP) equipment (e.g., pieces of equipment (i.e., blades) from the
(b)(4)
slicing machine) that are cleaned and sanitized in the
(b)(4)
sink.
In addition, your facility’s “27.0 ENVIRONMENTAL TESTING Last Revision 1/2016” document is not clear on the frequency of collecting environmental samples for pathogens, including
Salmonella
. In the “Purpose” section, the document states that “Testing is to occur at the
(b)(4)
procedures at
(b)(4)
.” However, in the “Background” section, the document indicates that
(b)(4)
for “
Salmonella sp
.” will be “collected quarterly.” The “Limit and Testing occurrences” in the “Procedures” section notes testing for Salmonella “at least annually.” Furthermore, the procedure does not indicate the analytical method that will be used.
In addition, you are not following your environmental monitoring procedure as specified in “27.0 ENVIRONMENTAL TESTING Last Revision 1/2016”. According to your procedure, samples including “
(b)(4)
,
(b)(4)
, and
(b)(4)
” will be taken, analyzed, and reported by
(b)(4)
. However, during the inspection, investigators were informed that your facility conducted environmental swabbing using
(b)(4)
swabs. These collections were recorded on the
(b)(4)
Chain of Custody forms, as demonstrated on forms dated
(b)(4)
and
(b)(4)
. An employee explained that no staff member from
(b)(4)
had been to your firm to collect environmental swabs, and no swabs were ever sent to
(b)(4)
for analysis. The employee further stated that environmental monitoring had been conducted in this manner for approximately 2.5 years. You affirmed and signed an affidavit regarding this practice. As such, your firm’s environmental monitoring program is not verifying the effectiveness of your sanitation controls for
Salmonella
.
Your response stated that you agree that your firm did not identify a hazard that required a preventive control in your “21.0 HACCP Last Revision 3/2024” for recontamination with environmental pathogens at the “Cooling, De-Panning, Slicing and Packaging” steps. You stated that your firm’s RTE breads are exposed to the environmental in the warehouse while cooling on racks, but there is a
(b)(4)
system “
(b)(4)
to minimize recontamination with environmental pathogens.” However, in your response, you did not provide an updated hazard analysis to identify that the hazard of recontamination of environmental pathogens requires a sanitation preventive control at the “Cooling, De-Panning, Slicing and Packaging” steps.
Furthermore, your response stated that you believe your written procedures for cleaning and sanitation, contained in your “
(b)(4)
Cleaning Checklist” documents, are adequate to significantly minimize or prevent this hazard from occurring, and that you have written procedures, monitoring records, and corrective actions for your sanitation activities. Your response included the “21.0 HACCP Last Revision 3/2024” to support that you have written procedures for cleaning and sanitation of all equipment. However, you have not included any documents describing sanitizer concentration and sanitation of utensils and COP equipment.
Additionally, your response stated that you do not agree that your firm’s sampling to determine sanitation effectiveness is inadequate, and that you identify specific testing procedures and adequate corrective actions. You further stated that you provided revised “Safety Operating Procedures” for environmental monitoring. However, the document that you provided, Attachment C “27.0 ENVIRONMENTAL TESTING Last Revision 6/2024,” appears identical to the written procedures obtained during the inspection, except for the document date, name of approving personnel, and a change in the name of laboratory performing the environmental sampling. You have not provided procedures that include, but not limited to, identifying the number of sample sites, the frequency of sampling, analytical method, and adequate corrective actions. In addition, your response does not address how you will ensure that your environmental monitoring program is implemented including ensuring the appropriate
(b)(4)
/swabs are used for detection of
Salmonella
and are sent to the laboratory for analysis. We will verify the implementation and adequacy of your corrective actions during the next FDA inspection.
2.    You did not establish and implement a risk-based supply chain program for those raw materials and ingredients for which you have identified a hazard requiring a supply-chain-applied control, as required by 21 CFR 117.405(a)(1). Specifically, you did not identify and implement a supply-chain preventive control to ensure control of ingredient-related pathogens. Your hazard analysis for RTE breads, rolls, and buns, “21.0 HACCP Last Revision 3/2024,” identified at receiving steps for wheat flour, whey
(b)(4)
, egg, and walnut ingredients, pathogens as a hazard associated with these ingredients used in your RTE products. Your hazard analysis further identified a supply-chain control to control the pathogen hazard. However, you do not have a written supply-chain program covering the pathogen hazard in the referenced ingredients. Furthermore, you do not approve your suppliers or conduct supplier verification activities. Your hazard analysis stated that the "Product is baked. Final baking is a kill step to control Pathogens.” However, you do not have a process preventive control (i.e., a written procedure with preventive control management components) at the baking step to address bacterial pathogens, such as
Salmonella
and pathogenic E. coli. Further, we note that you are not obtaining your desired cook temperatures.  According to your Vice President/General Manager, your employees check that
(b)(4)
temperatures are between
(b)(4)
°F to
(b)(4)
°F (
(b)(4)
). According to your “
(b)(4)
” for March 2024, maximum oven temperatures were as low as
(b)(4)
°F.
Your written response indicates that your firm requires that raw flour be tested by the supplier and have negative results before accepting a shipment. However, bacterial pathogens such as Salmonella and pathogenic E. coli are a hazard for which there is a reasonable probability that exposure will result in serious adverse health consequences or death, and thus an annual onsite audit is the appropriate supplier verification activity unless there is a written determination that other verification activities and/or less frequent onsite auditing of the supplier provide adequate assurance that the hazard is controlled (see 21 CFR 117.430(b)). The audit must be conducted before using the raw material or other ingredient from the supplier and at least annually thereafter, as required by 21 CFR 117.430(b)(1)(ii). Additionally, you do not have supply-chain controls for the whey
(b)(4)
, egg, and walnut ingredients, and you have not provided a written supply-chain control program.
Regarding your baking step, your response stated that each
(b)(4)
you monitor
(b)(4)
to ensure that products are baked at the correct temperature. In addition, you stated that oven calibrations are conducted every
(b)(4)
by your maintenance company. You provided third-party invoices for calibration of ovens with a “date completed” of
(b)(4)
,
(b)(4)
, and
(b)(4)
. You also provided an invoice that has a “date of order” of
(b)(4)
, however, it does not include a date when the work was completed or a signature acknowledging the work. You have not provided a written procedure for a baking process control and the required preventive control management components such as monitoring, corrective actions, and verification of your baking step. We will verify the implementation and adequacy of your corrective actions during the next FDA inspection, including a supply-chain or process preventive control to ensure control of ingredient-related pathogens.
3.    Your written allergen preventive control did not include procedures, practices, and processes for ensuring protection of food from allergen cross-contact, including during storage, handling, and use, and for food labeling to ensure the food is not misbranded under section 403(w) of the Act, as required by 21 CFR 117.135(c)(2). Specifically:
a.    Your hazard analysis, “21.0 HACCP Last Revision 3/2024”, for RTE breads, rolls, and buns identified undeclared allergens as a hazard requiring a preventive control at the Label step. The product formulas for these products include allergens such as egg, milk, wheat, walnuts, and sesame. Your “14.0 ALLERGEN CONTROL Last Revision 3/2024” indicates that “Ingredient labels are printed by an outside vendor. Labels shall adhere to all FDA requirements and each release shall be compared against an approved standard label kept on file.” However, your written allergen control procedure does not include monitoring, corrective actions, and verification procedures for undeclared allergens (see 21 CFR 117.140). Furthermore, the procedure did not indicate how you will ensure that the product is packaged with the correct label/allergen declaration or container.
In addition, you stated to investigators that when you begin packaging a new product, your employees check the label against the production sheet to make sure they have the correct label and package, highlight the production sheet, and then begin packaging. However, your employees do not check to make sure the labels have the correct allergens listed, when you begin packaging a new product, during label receipt, or at other times.
FDA previously issued your firm a Warning Letter (Reference #673138) on January 29, 2024 for failing to declare a major food allergen (i.e., milk) on the label of your Knickerbocker Homestyle Hamburger Buns, and for failing to comply with 21 CFR 117.135(a)(1) and (c)(2). In your written responses to the FDA Warning Letter dated February 21, 2024, and March 27, 2024, you did not include evidence that you have identified and implemented preventive controls addressing the hazard of undeclared allergens, including written procedures for monitoring, corrective actions, and verification.
Your written response states that your “production employees follow a procedure to ensure that the correct labeling is being used before packaging” and that you “will implement that the production sheets be signed by the employee doing the label checks.” The document, “14.0 ALLERGEN CONTROL Last Revision 3/2024,” included in your response, does not include monitoring, corrective actions, and verification procedures to ensure that the appropriate allergens are declared on the label. We will verify the implementation and adequacy of your corrective actions during the next FDA inspection.
b.    Your hazard analysis, “21.0 HACCP Last Revision 3/2024,” for RTE breads, buns, and rolls identified the hazard of allergen cross-contact as a hazard requiring a preventive control at the following steps: Receiving/Storage Ambient Ingredients (Whey
(b)(4)
), Receiving/Storage Ambient Ingredients (Egg), Mixing, Dividing, Forming/Rounding,
(b)(4)
, Conveyor, Crate, Tray or Box, and Receiving/Storage
(b)(4)
Ingredients (Walnut). Your facility manufactures a variety of products with different allergen profiles, such as egg, milk, walnuts, sesame, and wheat, on shared equipment and on the same production day. During the inspection, you stated that these allergens are used throughout all your processing equipment
(b)(4)
, and that your firm schedules production for products containing unlike or more allergens
(b)(4)
. Although your “14.0 ALLERGEN CONTROL Last Revision 3/2024” document identifies the allergens of whey, egg, wheat flour, walnuts, and sesame, your written procedures do not include procedures for preventing allergen cross-contact of wheat, walnuts, and sesame, such as how you will schedule production or cleaning for your products including these allergens. In addition, the document does not describe the steps to be taken to ensure that appropriate action is taken, when necessary, to reduce the likelihood that the problem will recur, that all affected food is evaluated for safety, and that all affected food is prevented from entering into commerce (see 21 CFR 117.150(a)(2)).
Your written response stated that your firm does not share equipment between allergen and non-allergen products, and all products that contain allergen items are produced at the end of each
(b)(4)
schedule. You further stated that the “utensils and equipment are cleaned and sanitized
(b)(4)
after the products containing allergens have been done.” However, you manufacture products with different allergen profiles on shared food-contact equipment on the same production day, and you have not provided written monitoring procedures, corrective actions, and verification procedures to address the hazard of allergen cross-contact for wheat, walnuts, and sesame.
(b)(4)
(b)(3)(A)
U.S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
5001 Campus Dr. (HFS-681)
College Park, MD 20740
You may also submit your waiver request by email to FURLS@fda.gov. The waiver request should include the facility name and address and the name of the owner, operator, or agent in charge of the facility.
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 your facility 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 without further notice, including, without limitation, seizure and injunction.
In addition, we offer the following comment:
Your food safety plan was not prepared, nor was its preparation overseen, by one or more preventive controls qualified individual(s), as required by 21 CFR 117.126(a)(2). Your hazard analysis indicates that it was approved by you, President/Owner (Sandra Sokana). You stated to investigators that you are not your firm’s preventive controls qualified individual (PCQI) and that you
(b)(4)
. Furthermore, there are no PCQI trained individuals or individuals who are qualified through experience to develop and apply a food safety system. In your written response, you stated that your firm intends to have an employee take the training course and become a preventative controls qualified individual soon.
Please notify FDA in writing, within fifteen (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 any documentation. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the timeframe within which you will do so. If you believe that your products are not in violations of the Act, include your reasoning and any supporting information for our consideration.
Please send your written response to Daniel Arrecis, Compliance Officer, at ORAHAFEAST6FirmResponses@fda.hhs.gov.  Alternatively, you may mail your response to Daniel Arrecis, 550 W. Jackson Suite 800 Chicago, IL 60661.  If you should have any questions regarding this letter, please contact Daniel Arrecis at (312) 596-4263.
Sincerely,
/S/
William R. Weissinger, MS
Program Division Director
Office of Human and Animal Foods Operations East
Division 6
Content current as of:
12/10/2024
Regulated Product(s)
Food & Beverages