- Delivery Method:
- United Parcel Service
- Food & Beverages
Recipient NameChris Furman
Recipient TitlePresident and CEO
- Ventura Foods LLC
40 Pointe Drive
Brea, CA 92821
- Issuing Office:
- Division of Human and Animal Food Operations East V
October 28, 2020
WARNING LETTER 609201
Dear Mr. Furman:
The United States Food and Drug Administration (FDA) has determined that your recalled Garlic Parmesan Sauce labeled as Garlic Sauce, which was manufactured by your Birmingham, AL facility, 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 major food allergens (milk and wheat). 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 (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 home page at http://www.fda.gov.
On May 14, 2020, your firm recalled the Garlic Parmesan Sauce labeled as Garlic Sauce after being notified by your customer of the mislabeled product. Your Garlic Parmesan Sauce contains milk and wheat, and your Garlic Sauce does not and so does not declare these allergens on the label. In documentation included with your July 15, 2020, email to the Office of Human and Animal Food Operations West Division 5 Recall Coordinator, you indicated that the mislabeling occurred because an operator brought an incorrect roll of labels to the line. Although your firm identified the mislabeling issue before the product left your facility, you did not re-label all affected jugs of product. Your July 15 email identified four causes and provided your firm’s corrective and preventive actions. In particular, you indicated that you: improved label management process to pre-stage labels for each line and limit label room access; updated your procedure for label conversions and storage of new labels; required barcode scanning of gallon jugs; updated a procedure to include details on how to properly escalate and manage nonconforming product; updated a procedure to outline details regarding the proper handling of relabeling tasks; and will conduct training on all updated procedures by July 1, 2020. We will
verify implementation of any corrective actions during FDA’s next inspection of your facility.
You did not identify and implement preventive controls to provide assurances that any hazard requiring a preventive control (i.e., undeclared allergens) will be significantly minimized or prevented and the food manufactured, processed packed or held by your facility will not be
adulterated under section 402 or 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 labeling step adequate to significantly minimize or prevent the hazard of undeclared allergens as evidenced by your firm applying the Garlic Sauce label to your Garlic Parmesan Sauce. This incorrect labeling caused your product to contain undeclared major food allergens.
Further, you did not implement effective corrective action procedures that must be taken if preventive controls are not properly implemented, as required by 21 CFR 117.150(a)(2)(iii) and (iv). Specifically, your corrective actions did not ensure that all affected product was evaluated for safety and prevented from entering commerce when your product was misbranded under section 403(w) of the Act, as evidenced by mislabeled Garlic Parmesan Sauce that reached customers.
Under section 201(qq) of the Act [21 U.S.C. § 321(qq)], milk and wheat are considered “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)].
Your recalled Garlic Parmesan Sauce labeled as Garlic Sauce is 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 major food allergens (milk and wheat).
This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring that your facility operates in compliance with the Act, the CGMP & PC rule, and other applicable laws. You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by the FDA without further notice, including, without limitation, seizure and injunction.
We will verify implementation of any corrective actions during FDA’s next inspection of your facility. If you would like to provide further details pertaining to the corrective actions taken by your firm and provide documentation, including revised procedures and completed monitoring records that would assist us in evaluating your corrections, please notify this office in writing within fifteen (15) working days of the receipt of this letter.
If you believe that your products are not in violation of the Act or that you have complied with FDA regulations, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.
Your reply should be addressed to the U.S. Food and Drug Administration; Attn: Christopher N. Dedeaux, Compliance Officer, via email at ORAHAFEAST5FirmResponses@fda.hhs.gov or at 404 BNA Drive, Suite 500, Nashville, TN 37217. You may reach Mr. Dedeaux at 504-846-6122 or via email at Christopher.Dedeaux@fda.hhs.gov if you have any questions about this matter.
Steven B. Barber
Program Division Director
Office of Human and Animal Food Operations
Division East 5