- Delivery Method:
- Via Email
- Reference #:
- Food & Beverages
- Issuing Office:
- Division of Human and Animal Food Operations East IV
August 10, 2020
20-HAFE4-WL-06/CMS No. 608227
Dear Mr. Pero:
The United States Food and Drug Administration (FDA) has determined that your recalled Zucchini Spiral Pesto Side Dish Kits 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 major food allergens (egg and 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 (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 March 10, 2020, after being notified by a customer of the mislabeled product, your firm recalled Zucchini Spiral Pesto Side Dish Kits. The Zucchini Spiral Pesto Side Dish Kits were mislabeled with a sweet teriyaki veggie rice back panel label that does not declare egg and milk ingredients. In documentation included with your March 11, 2020, e-mail to the Office of Human and Animal Food Operations East Division 4 Recall Coordinator (DRC) you indicated (b)(4).” You provided your firm’s corrective and preventive actions to the DRC by email on April 9, 2020, stating, “(b)(4).” 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 (b)(4) step adequate to significantly minimize or prevent the hazard of undeclared allergens as evidenced by your firm applying the incorrect back panel label onto your Zucchini Spiral Pesto Side Dish Kits. This incorrect labeling caused your product to contain undeclared major food allergens.
Under section 201(qq) of the Act [21 U.S.C. § 321(qq)], egg and milk 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 Zucchini Spiral Pesto Side Dish Kits 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 major food allergens (egg and milk).
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 do not believe that your products are in violation of the Act, 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 written response should be directed to the Food and Drug Administration, attention to: Ms. Wanda J. Torres, Office of Human and Animal Food Operations Division East 4, 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901, POC address or e-mail at Wanda.Torres@fda.hhs.gov. If you have questions regarding this letter, please contact (787) 729-8709.
Ramon A. Hernandez
Program Division Director
Office of Human and Animal Food Operations
Division East IV
Director, San Juan District Office
Copy sent via e-mail to:
Ms. Angela Pero, President
Pero Family Farms Food Company, LLC