A summary of the events:
- On September 12, 2023, the firm recalled Knickerbocker Homestyle Hamburger Buns after the firm discovered that the product contained milk, but the printed package did not contain an allergen statement or ingredient declaration for milk.
- The firm became aware of this undeclared milk after being notified during a Michigan Department of Agriculture and Rural Development (MDARD) inspection at the facility on September 12, 2023 of a complaint received by MDARD on September 11, 2023 that indicated a customer had an allergic reaction to milk after consuming the product.
- In documentation provided to FDA on September 15, 2023, the firm stated that they had reformulated the bun product to include milk powder without changing the packaging to reflect the change. This product had been manufactured on August 31, 2023, and September 1, 2, 6, 7, 8, 9, 11, 2023 at the facility with packaging that did not declare milk on the label.
- On September 15, 2023, the firm provided documentation that stated that they had determined the root cause to be “Dough formulation change without changing the packaging to reflect the change.” The proposed action to prevent reoccurrence indicated that there would be no formulation changes without the signatures of the buyers and the owners.
- On September 18, 2023, FDA sent the firm an email giving the firm an opportunity to provide FDA additional corrective actions to address the root cause of the undeclared major food allergen involved in your recall; however, the firm did not respond.
- Conclusion - Knickerbocker Homestyle Hamburger Buns, which contain milk, are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)], in that the finished product label fails to declare a major food allergen (milk).
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/knickerbocker-365-inc-673138-01292024
WARNING LETTER
Knickerbocker 365, Inc.
MARCS-CMS 673138 — JANUARY 29, 2024
Recipient:
Mr. Firas Hanna
President
Knickerbocker 365, Inc.
26040 Pinehurst Drive
Madison Heights, MI 48071
United States
firashanna24@yahoo.com
Issuing Office:
Division of Human and Animal Food Operations East VI
United States
WARNING LETTER
CMS 673138
January 29, 2024
Dear Mr. Hanna:
The United States Food and Drug Administration (FDA) has determined that your recalled product, Knickerbocker Homestyle Hamburger Buns (16 oz. retail unit, lot codes I31C, J01C, J02C, J06C, J07C, J08C, J09C, & J11C (UPC 611625100206)) are misbranded within the meaning of section 403(w) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343(w)], in that the finished product label did not declare a major food allergen, milk. Further, we have determined that you did not follow the requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule) (21 CFR Part 117). The 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 (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 home page at www.fda.gov.
On September 12, 2023, your firm recalled Knickerbocker Homestyle Hamburger Buns after you discovered that the product contained milk, but the printed package did not contain an allergen statement or ingredient declaration for milk. Your firm became aware of the undeclared milk after being notified during a Michigan Department of Agriculture and Rural Development (MDARD) inspection at your facility on September 12, 2023 of a complaint received by MDARD on September 11, 2023 that indicated a customer had an allergic reaction to milk after consuming Knickerbocker Homestyle Hamburger Buns. In documentation provided to the Office of Human and Animal Food Operations (OHAFO) East 6 Recall Coordinator on September 15, 2023, you indicated that your firm reformulated Knickerbocker Homestyle Hamburger Buns to include milk powder without changing the packaging to reflect the change. This product was manufactured on August 31, 2023, and September 1, 2, 6, 7, 8, 9, 11, 2023 at your facility with packaging that did not declare milk on the label.
On September 15, 2023, you provided documentation that stated that you determined the root cause to be “Dough formulation change without changing the packaging to reflect the change.” Your proposed action to prevent reoccurrence indicated that there would be no formulation changes without the signatures of the buyers and the owners. On September 18, 2023, FDA sent you an email giving you an opportunity to provide FDA additional corrective actions to address the root cause of the undeclared major food allergen involved in your recall; however, you did not respond. We will verify the adequacy and implementation of any corrective actions during FDA’s next inspection of your facility.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C)
You did not identify and implement preventive controls to provide assurances that any hazard requiring a preventive control (e.g., undeclared allergens) will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be misbranded under section 403(w) of the Act, as required by 21 CFR 117.135(a)(1) and (c)(2). Specifically, you did not identify and implement food allergen controls at the packaging/labeling step to significantly minimize or prevent the hazard of undeclared allergens, as evidenced by your firm reformulating the Knickerbocker Homestyle Hamburger Buns to include the major food allergen milk without changing the ingredient labeling for buns manufactured between August 31 and September 11, 2023. This incorrect labeling resulted in undeclared milk, a major food allergen, in your Knickerbocker Homestyle Hamburger Buns.
Misbranding
Under section 201(qq) of the Act [21 U.S.C. § 321(qq)], milk is considered a “major food allergen.” A food is misbranded under section 403(w) of the Act if it is not a raw agricultural commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either:
The word “Contains” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients, as required by section 403(w)(1)(A) of the Act [21 U.S.C. § 343(w)(1)(A)]; or
The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived (e.g., “Whey (Milk)”), except the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), section 403(w)(1)(B) of the Act [21 U.S.C. § 343(w)(1)(B)].
Your Knickerbocker Homestyle Hamburger Buns, which contain milk, are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)], in that the finished product label fails to declare a major food allergen (milk).
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 to Compliance Officer Daniel Arrecis, via email at ORAHAFEAST6FirmResponses@fda.hhs.gov. If you should have any questions regarding this letter, please contact Daniel Arrecis, Compliance Officer, at (312) 596-4263 or via email, daniel.arrecis@fda.hhs.gov.
Sincerely,
/S/
William R. Weissinger, MS
Program Division Director
Office of Human and Animal Foods East
Division 6
Mr. Firas Hanna
President
Knickerbocker 365, Inc.
26040 Pinehurst Drive
Madison Heights, MI 48071
United States
firashanna24@yahoo.com
Issuing Office:
Division of Human and Animal Food Operations East VI
United States
WARNING LETTER
CMS 673138
January 29, 2024
Dear Mr. Hanna:
The United States Food and Drug Administration (FDA) has determined that your recalled product, Knickerbocker Homestyle Hamburger Buns (16 oz. retail unit, lot codes I31C, J01C, J02C, J06C, J07C, J08C, J09C, & J11C (UPC 611625100206)) are misbranded within the meaning of section 403(w) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343(w)], in that the finished product label did not declare a major food allergen, milk. Further, we have determined that you did not follow the requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule) (21 CFR Part 117). The 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 (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 home page at www.fda.gov.
On September 12, 2023, your firm recalled Knickerbocker Homestyle Hamburger Buns after you discovered that the product contained milk, but the printed package did not contain an allergen statement or ingredient declaration for milk. Your firm became aware of the undeclared milk after being notified during a Michigan Department of Agriculture and Rural Development (MDARD) inspection at your facility on September 12, 2023 of a complaint received by MDARD on September 11, 2023 that indicated a customer had an allergic reaction to milk after consuming Knickerbocker Homestyle Hamburger Buns. In documentation provided to the Office of Human and Animal Food Operations (OHAFO) East 6 Recall Coordinator on September 15, 2023, you indicated that your firm reformulated Knickerbocker Homestyle Hamburger Buns to include milk powder without changing the packaging to reflect the change. This product was manufactured on August 31, 2023, and September 1, 2, 6, 7, 8, 9, 11, 2023 at your facility with packaging that did not declare milk on the label.
On September 15, 2023, you provided documentation that stated that you determined the root cause to be “Dough formulation change without changing the packaging to reflect the change.” Your proposed action to prevent reoccurrence indicated that there would be no formulation changes without the signatures of the buyers and the owners. On September 18, 2023, FDA sent you an email giving you an opportunity to provide FDA additional corrective actions to address the root cause of the undeclared major food allergen involved in your recall; however, you did not respond. We will verify the adequacy and implementation of any corrective actions during FDA’s next inspection of your facility.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C)
You did not identify and implement preventive controls to provide assurances that any hazard requiring a preventive control (e.g., undeclared allergens) will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be misbranded under section 403(w) of the Act, as required by 21 CFR 117.135(a)(1) and (c)(2). Specifically, you did not identify and implement food allergen controls at the packaging/labeling step to significantly minimize or prevent the hazard of undeclared allergens, as evidenced by your firm reformulating the Knickerbocker Homestyle Hamburger Buns to include the major food allergen milk without changing the ingredient labeling for buns manufactured between August 31 and September 11, 2023. This incorrect labeling resulted in undeclared milk, a major food allergen, in your Knickerbocker Homestyle Hamburger Buns.
Misbranding
Under section 201(qq) of the Act [21 U.S.C. § 321(qq)], milk is considered a “major food allergen.” A food is misbranded under section 403(w) of the Act if it is not a raw agricultural commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either:
The word “Contains” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients, as required by section 403(w)(1)(A) of the Act [21 U.S.C. § 343(w)(1)(A)]; or
The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived (e.g., “Whey (Milk)”), except the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), section 403(w)(1)(B) of the Act [21 U.S.C. § 343(w)(1)(B)].
Your Knickerbocker Homestyle Hamburger Buns, which contain milk, are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)], in that the finished product label fails to declare a major food allergen (milk).
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 to Compliance Officer Daniel Arrecis, via email at ORAHAFEAST6FirmResponses@fda.hhs.gov. If you should have any questions regarding this letter, please contact Daniel Arrecis, Compliance Officer, at (312) 596-4263 or via email, daniel.arrecis@fda.hhs.gov.
Sincerely,
/S/
William R. Weissinger, MS
Program Division Director
Office of Human and Animal Foods East
Division 6
No comments:
Post a Comment