WARNING LETTER
Lipari Foods Operating Company, LLC
MARCS-CMS 669083 —
April 09, 2024
Delivery Method:
VIA EMAIL AND UNITED PARCEL SERVICE
Product:
Food & Beverages
Recipient:
Recipient Name
Thom Lipari
Recipient Title
President
Lipari Foods Operating Company, LLC
26661 Bunert Road
Warren
,
MI
48089-3650
United States
Thom_Lipari@liparifoods.com
Issuing Office:
Division of Human and Animal Food Operations East VI
United States
WARNING LETTER
CMS 669083
April 9, 2024
Dear Mr. Lipari:
The United States Food and Drug Administration (FDA) has determined that the following recalled products manufactured by your facility, JLM Manufacturing LLC, 14285 Frazho Rd., Warren, MI 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 labels did not declare a major food allergen:
IO Inspired Organics brand Organic Raw Walnut Halves & Pieces (7oz plastic tubs 943469, UPC 863669740065) with batch number 21202306A and expiration 6/21/2024 due to undeclared walnuts on the bottom label of the product.
Filberts/hazelnuts labeled as “JLM brand Roasted Salted Pecan Halves” (10oz clear plastic container UPC 094776110049) with lot number 09202306A due to undeclared filberts/hazelnuts on the principal display panel.
Cashews labeled as “IO Inspired Organics brand Raw Walnuts” (5oz bag, UPC 8 63669 74200 7) with lot number 12202307A due to undeclared cashews on the finished product label.
The introduction or delivery for introduction into interstate commerce of any food that is misbranded is prohibited by section 301(a) of the Act [21 U.S.C. § 331(a)]. You may find the Act through links in FDA's home page at http://www.fda.gov.
Further, we have determined that your subsidiary 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 http://www.fda.gov.
On August 1, 2023, after being notified of a complaint from a retail store, your firm recalled tubs of the IO Inspired Organics brand Organic Raw Walnut Halves & Pieces. The product was mislabeled with a bottom label identifying the product as cashews in the name, ingredient, and contains statements. The bottom label did not declare walnuts in the ingredient statement or the "Contains” statement.
On September 6, 2023, after being notified of a complaint from a retail store, your firm recalled raw filberts/hazelnuts that were mislabeled as “JLM brand Roasted Salted Pecan Halves.” The product was mislabeled with a principal display panel that incorrectly identified the product as Roasted Salted Pecan Halves, while the package contained raw filberts/hazelnuts and the principal display panel did not declare filberts/hazelnuts.
On September 9, 2023, after being notified of a complaint by a retail store, your firm recalled the cashews that were mislabeled as “IO Inspired Organics Raw Walnuts.” The product was mislabeled in the pouch for Raw Walnuts while the package contained cashews. The pouch did not declare cashews.
On August 15, September 14, and September 18, 2023, corrective and preventive action documentation was provided to the Office of Human and Animal Food Operations East Division 6 Recall Coordinator for the three recalls, respectively. This documentation indicates that on August 15, 2023, your policies were updated, employees were re-trained, and production paperwork was amended to include label retention samples
(b)(4)
. Further, that labels are verified by QA
(b)(4)
. We will verify 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 adequate 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 adequate to significantly minimize or prevent the hazard of undeclared allergens, as evidenced by the three mislabeling occurrences describe above. This incorrect labeling resulted in undeclared walnuts, filberts/hazelnuts, and cashews in your Organic Raw Walnut Halves & Pieces, Filberts/hazelnuts labeled as, “JLM brand Roasted Salted Pecan Halves”, and Cashews labeled as, “IO Inspired Organics brand Raw Walnuts” respectively.
Misbranding
Walnuts, Filbert/Hazelnuts, and Cashews are considered “major food allergens” under section 201(qq) of the Act [21 U.S.C § 321(qq)]. 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)].
Your recalled IO Inspired Organics brand Organic Raw Walnut Halves & Pieces, JLM brand Roasted Salted Pecan Halves, and IO Inspired Organics brand Raw Walnuts are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)], in that the finished product labels failed to declare major food allergens.
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 firm and your subsidiary complies with all requirements of federal law, including FDA regulations.
You should take prompt action to address all violations noted in this letter. Failure to promptly correct these violations may result in legal action by FDA without further notice, including seizure and/or injunction.
Please notify FDA in writing within 15 working days from your 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 Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within 15 working days, state the reason for the delay and the time within which you will do so.
Your firm’s response should be sent to Lauren Sexton, Compliance Officer, via e-mail at Lauren.Sexton@fda.hhs.gov. If you have any questions about this letter, please contact Lauren Sexton at (313) 393-8179 or via e-mail.
Sincerely,
/S/
William R. Weissinger, MS
Program Division Director
Office of Human and Animal Food Operations
Division East 6
Content current as of:
04/16/2024
Regulated Product(s)
Food & Beverages