So FDA issued a Warning Letter for not identifying and implementing food allergen controls adequate to significantly minimize or prevent the hazard of undeclared allergens as evidenced by [the] firm using an incorrect masterpack in your Tuscan Herb Chopped Salad Kit. This masterpack addition error caused {the] product to contain undeclared major food allergens."
FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dole-fresh-vegetables-inc-608414-09252020
Dole Fresh Vegetables, Inc.
MARCS-CMS 608414 — September 25, 2020
Recipient:
Michael Solomon
President
Dole Fresh Vegetables, Inc.
2959 Salinas Hwy
Monterey, CA 93940
United States
Issuing Office:
Division of Human and Animal Food Operations West V
United States
WARNING LETTER
September 25, 2020
CMS#608414
Dear Mr. Solomon:
The United States Food and Drug Administration (FDA) has 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.
External Link Disclaimer
On March 6, 2020, after being notified by your customer that three consumers reported that the incorrect masterpack was found in HEB brand Tuscan Herb Chopped Salad Kit, your firm recalled the product. You indicated in your press release that the mislabeling occurred when “[t]he incorrect masterpack (kit with dressing and other toppings) was unintentionally used during the production of the salad.” The masterpack used held dressing that contained peanut butter and almond, cashew, and chow mein noodle (wheat) toppings. In documentation provided to the Office of Human and Animal Food Operations West Division 5 Recall Coordinator on April 9, 2020, your firm indicated that the cause was that you “did not have a robust enough verification process for product changeover.” The documentation further stated that the preventive actions taken were “Modification of Masterpack consumption form (b)(4)" and “Implementation of Masterpack verification (b)(4).” We will verify implementation of any corrective actions during FDA’s next inspection of your facility.
Preventive Controls
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 adequate to significantly minimize or prevent the hazard of undeclared allergens as evidenced by your firm using an incorrect masterpack in your Tuscan Herb Chopped Salad Kit. This masterpack addition error caused your product to contain undeclared major food allergens.
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 written response should be sent to:
Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
1201 Harbor Bay Parkway
Alameda, CA 94502
Refer to Unique Identification Number CMS Case #608414 when replying.
If you have any questions regarding this letter, please contact Marjorie Schultz, Recall Coordinator/Compliance Officer, at Marjorie.schultz@fda.hhs.gov or 510-337-6898.
Sincerely,
/S/
Darla R. Bracy
District Director | FDA San Francisco District
Program Division Director
Office of Human and Animal Food Operations –West Division 5
cc:
Hugo Villagomez, Plant Manager
Dole Fresh Vegetables, Inc.
32655 Camphora Gloria Road
Soledad, CA 93960
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