The company provided FDA the reason for mistake - "stated that the root cause of the problem was that an employee failed to follow the label change over procedure and performed an unauthorized label change. The email also stated that you retrained all employees that perform labeling, took disciplinary action against the employee that performed the unauthorized change, and that you will develop a label reconciliation program." In response FDA stated "it appears that you did not implement adequate allergen preventive controls."
The responsibility should not be on one employee, but a Preventive Control that incorporates monitoring and verification by additional employees.
FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cedars-mediterranean-foods-inc-623473-02112022
Cedar’s Mediterranean Foods Inc.
MARCS-CMS 623473 — FEBRUARY 11, 2022
FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cedars-mediterranean-foods-inc-623473-02112022
Cedar’s Mediterranean Foods Inc.
MARCS-CMS 623473 — FEBRUARY 11, 2022
Recipient:
Mr. Charles L. Hanna
President and CEO
Cedar’s Mediterranean Foods Inc.
50 Foundation Ave
Ward Hill, MA 01835-6926
United States
Issuing Office:
Office of Human and Animal Food Operations East – Division 1
United States
WARNING LETTER
CMS # 623473
Mr. Charles L. Hanna, President and CEO
Cedar’s Mediterranean Foods Inc.
50 Foundation Ave
Ward Hill, MA 01835-6926
Dear Mr. Hanna:
The United States Food and Drug Administration (FDA) has determined that your recalled Cedar’s Organic Mediterranean Hommus labeled with the ingredient declaration for your Organic Everything Hommus is 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 labels did not declare a major food allergen--tree nuts (i.e., Pine Nut).
On October 25, 2021, after being notified by your consignee of the mispackaged product, your firm recalled Cedar’s Organic Mediterranean Hommus that were labeled with the ingredient declaration for Organic Everything Hommus. You indicated in your press release that the product “may contain an incorrect back label and undeclared allergen (Pine Nut).”
In your November 15, 2021 email to the Office of Human and Animal Food Operations East Division 1 Recall Coordinator, you further stated that the root cause of the problem was that an employee failed to follow the label change over procedure and performed an unauthorized label change. The email also stated that you retrained all employees that perform labeling, took disciplinary action against the employee that performed the unauthorized change, and that you will develop a label reconciliation program. We will verify implementation of any corrective actions during FDA’s next inspection of your facility.
Misbranding:
Your recalled Organic Mediterranean Hommus is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)], in that the finished product labels fail to declare a major food allergen--tree nuts (i.e., Pine Nuts) as required by section 403(w)(1) of the Act. Specifically, your Organic Mediterranean Hommus contained an incorrect back label and undeclared allergen (Pine Nut).
Section 201(qq) of the Act [21 U.S.C. § 321(qq)], defines milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils as “major food allergens.” 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, 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)].
Additional comments:
Your facility is subject to the requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP and PC rule) (21 CFR Part 117). As such, you are required to 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 facilities will not be adulterated under section 402 or misbranded under section 403(w) of the Act (21 CFR 117.135(a)(1) and (c)(2)). 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) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)].
Based on the information you provided to FDA and the mislabeling of Organic Mediterranean Hommus containers with the ingredient declaration for Organic Everything Hommus, it appears that you did not implement adequate allergen preventive controls.
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above 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. You should take prompt action to correct or implement corrections to the violations cited in this letter. Failure to do so may result in legal action without further notice, including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these matters within 15 working days, state the reason for the delay and the time within which you will do so.
Your written response should be directed to the Food and Drug Administration, attention to Melissa Henaghan, Division Recall Coordinator, One Winners Circle, Suite 140, Albany, NY 12205, or email (preferred) at melissa.henaghan@fda.hhs.gov. If you have questions regarding this letter, please contact Melissa Henaghan at 518-453-2314 x1017.
Sincerely,
/S/
Ronald M. Pace
Program Division Director
Office of Human and Animal Food Operations
East – Division 1
Cc:
Mr. Nicholas Scangas, Chief Operating Officer
Cedar’s Mediterranean Foods Inc.
50 Foundation Ave
Ward Hill, MA 01835-6926
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