The company had similar recalls.
- One being on September 19, 2022, where the expanded this recall after being notified by the customer of another lot of 365 Organic Creamy Caesar mislabeled with 365 Organic Classic Ranch Dressing and Dip back panel ingredient labels that do not declare wheat and soy.
- On April 4, 2022, 365 Organic Creamy Caesar Dressing was recalled because of an incorrect back panel for Whole Foods Market Organic Blue Cheese applied to the product, which did not declare the allergens of wheat and soy
This is a pretty easy problem to fix if utilizing a properly designed Allergen Preventive Control for label application.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/vanlaw-food-products-inc-641010-01052023
Vanlaw Food Products, Inc
MARCS-CMS 641010 — JANUARY 05, 2023
Recipient:
Mr. Pablo Gallo Llorente
President
Vanlaw Food Products, Inc
1851 North Delilah St.
Corona, CA 93879
United States
MARCS-CMS 641010 — JANUARY 05, 2023
Recipient:
Mr. Pablo Gallo Llorente
President
Vanlaw Food Products, Inc
1851 North Delilah St.
Corona, CA 93879
United States
Issuing Office:
Division of Human and Animal Food Operations West V
United States
WARNING LETTER
January 5, 2023
CMS#641010
Dear Mr. Llorente,
The United States Food and Drug Administration (FDA) has determined that your recalled Whole Foods 365 Organic Creamy Caesar Dressing sold in 10 fl. oz. clear glass bottles 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 label did not declare major food allergens, wheat and soy. 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.External Link Disclaimer
Your firm recalled Whole Foods brand 365 Organic Creamy Caesar Dressing on August 25, 2022 after being notified by your customer that the back panel of the product was mislabeled with 365 Organic Classic Ranch Dressing and Dip back panel ingredient labels that did not declare wheat and soy. This product was manufactured on July 6, 2022 (Best by: April 6, 2023). In documentation provided to the Office of Human and Animal Food Operations West Division 5 Recall Coordinator on September 19, 2022, you indicated that work in progress for relabeling Classic Ranch Dressing and Dip was performed, but not monitored, and that it was possible that a few bottles with the wrong back label were inadvertently placed on the line by a temporary employee. You also indicated that relabeling was performed in the same area where the product was being packed, that relabeling did not go through the established process of verification, and that relabeling was not considered part of the workflow process.
On September 19, 2022, you expanded this recall after being notified by your customer of another lot of 365 Organic Creamy Caesar mislabeled with 365 Organic Classic Ranch Dressing and Dip back panel ingredient labels that do not declare wheat and soy. This lot was manufactured on August 2, 2022 (Best by: May 3, 2023).
Furthermore, your firm recalled the same product, Whole Foods brand 365 Organic Creamy Caesar Dressing on April 4, 2022, because of an incorrect back panel for Whole Foods Market Organic Blue Cheese applied to the product, which did not declare the allergens of wheat and soy.
On September 2 and September 19, 2022, you provided information pertaining to corrective actions to be taken at the Label Storage and Issue step and the Process Line. 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 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 incorrect back panel label to your 365 Organic Creamy Caesar Dressing on July 6 and August 2, 2022 and the information you provided to FDA. This incorrect labeling resulted in undeclared wheat and soy in your 365 Organic Creamy Caesar Dressing.
Misbranding
Under section 201(qq) of the Act [21 U.S.C. § 321(qq)], soy 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 365 Organic Creamy Caesar Dressing 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 (wheat and soy).
This letter is not intended to be an all‐inclusive list of violations that exist 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 firm complies with all requirements of federal law and implementing regulations. You should take prompt action to correct all violations noted in this letter, if not already corrected. Failure to promptly correct these violations may result in enforcement action by FDA without further notice, including seizure and/or injunction.
You should respond in writing within fifteen (15) working days from your receipt of this letter.
Your written response should include the specific things you are doing to address these violations. You should include in your response documentation and information that would assist us in evaluating your corrections and plans to prevent recurrences. If you believe you have complied with the Act, include your reasoning and any supportive information for our consideration. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
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#) 641010 when replying.
If you prefer to send your response electronically, please email it to ORAHAFWEST5FirmResponses@fda.hhs.gov. Please include the name of your firm and the Unique Identification number in the title of the e-mail message.
If you have any questions regarding this letter, please contact David LaPlante, Compliance Officer, at David.laplante@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
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 365 Organic Creamy Caesar Dressing 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 (wheat and soy).
This letter is not intended to be an all‐inclusive list of violations that exist 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 firm complies with all requirements of federal law and implementing regulations. You should take prompt action to correct all violations noted in this letter, if not already corrected. Failure to promptly correct these violations may result in enforcement action by FDA without further notice, including seizure and/or injunction.
You should respond in writing within fifteen (15) working days from your receipt of this letter.
Your written response should include the specific things you are doing to address these violations. You should include in your response documentation and information that would assist us in evaluating your corrections and plans to prevent recurrences. If you believe you have complied with the Act, include your reasoning and any supportive information for our consideration. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
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#) 641010 when replying.
If you prefer to send your response electronically, please email it to ORAHAFWEST5FirmResponses@fda.hhs.gov. Please include the name of your firm and the Unique Identification number in the title of the e-mail message.
If you have any questions regarding this letter, please contact David LaPlante, Compliance Officer, at David.laplante@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
No comments:
Post a Comment