FDA issued a Warning Letter to Simple Truths for misbranding product after a mislabeling issue resulted in a allergen related recall. In this case, Ranch dressing containers were filled with Caesar Dressing in which case the label did not declare soy as an allergen. The issue stated by the company occurred "because the work in progress bulk containers used to produce the recalled Plant Based Ranch Dressing were mislabeled."
FDA also found issue in the corrective action provided by the company to FDA. In the Warning Letter, FDA states that the company's corrective action documentation indicates "that [the company] updated task instructions and will improve (b)(4) communication, limit formulation operators to pumping out (b)(4), require employees to (b)(4), and (b)(4) on the new task instructions. [The company] did not provide updated procedures, task instructions, or training records. [FDA} will verify implementation of any corrective actions during FDA’s next inspection of [the] facility."
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/litehouse-inc-662949-11292023
WARNING LETTERLitehouse, Inc.
MARCS-CMS 662949 — NOVEMBER 29, 2023
Recipient:
Kelly Prior
President and CEO
Litehouse, Inc.
100 Litehouse Drive
Sandpoint, ID 83864-0528
United States
Issuing Office:
Office of Human and Animal Food Operations Division East 6
United States
November 29, 2023
WARNING LETTER
Dear Mr. Prior:
Kelly Prior
President and CEO
Litehouse, Inc.
100 Litehouse Drive
Sandpoint, ID 83864-0528
United States
Issuing Office:
Office of Human and Animal Food Operations Division East 6
United States
November 29, 2023
WARNING LETTER
Dear Mr. Prior:
The United States Food and Drug Administration (FDA) has determined that your recalled Simple Truth brand Plant Based Ranch Dressing with lot code 1713802052623 and best if used by date “05 23 23”, which was manufactured at your (b)(4), 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 a major food allergen, soy. 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.
On April 19, 2023, your firm recalled Simple Truth brand Plant Based Ranch Dressing after investigation of consumer complaints that you received. In documentation provided to Office of Human and Animal Food Operations East Division 6 Recall Coordinator on April 25 and June 6, 2023, you indicate that the Plant Based Ranch Dressing product containers were filled with (b)(4) Caesar Dressing because the work in progress bulk containers used to produce the recalled Plant Based Ranch Dressing were mislabeled. The Caesar Dressing contained a soy allergen that was not declared on the Plant Based Ranch Dressing label. In addition, your firm has initiated two recalls in 2021 involving mislabeled or incorrectly filled products resulting in undeclared major food allergens.
You also provided corrective action information with the June 6, 2023, documentation where you indicate that you updated task instructions and will improve (b)(4) communication, limit formulation operators to pumping out (b)(4), require employees to (b)(4), and (b)(4) on the new task instructions. You did not provide updated procedures, task instructions, or training records. We will verify implementation of any corrective actions during FDA’s next inspection of your facility.
Misbranding
Under section 201(qq) of the Act [21 U.S.C. § 321(qq)], soy is considered a “major food allergen”. 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 Plant Based Ranch 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 a major food allergen (soy).
Additional Comments
Your facility is subject to the requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP and PC rule) (21 CFR Part 117). As such, you are required to identify and implement preventive controls 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 facilities will not be adulterated under section 402 or misbranded under section 403(w) of the Act (21 CFR 117.135(a)(1) and (c)(2)). 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) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)].
The violations cited in this letter are not intended to be an all‐inclusive list of violations that exist in connection with your marketed 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 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 address these violations may result in enforcement 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, you should explain the reason for your delay and state when you will correct any remaining violations.
Your firm’s response should be sent to Katie Cutajar, Compliance Officer, via e-mail at Kathryn.Cutajar@fda.hhs.gov. If you have any questions about this letter, please contact Katie Cutajar at (313) 680-6962 or via e-mail.
Sincerely,
/S/
William R. Weissinger, MS
Program Division Director
Office of Human and Animal Food Operations
Division East 6
On April 19, 2023, your firm recalled Simple Truth brand Plant Based Ranch Dressing after investigation of consumer complaints that you received. In documentation provided to Office of Human and Animal Food Operations East Division 6 Recall Coordinator on April 25 and June 6, 2023, you indicate that the Plant Based Ranch Dressing product containers were filled with (b)(4) Caesar Dressing because the work in progress bulk containers used to produce the recalled Plant Based Ranch Dressing were mislabeled. The Caesar Dressing contained a soy allergen that was not declared on the Plant Based Ranch Dressing label. In addition, your firm has initiated two recalls in 2021 involving mislabeled or incorrectly filled products resulting in undeclared major food allergens.
You also provided corrective action information with the June 6, 2023, documentation where you indicate that you updated task instructions and will improve (b)(4) communication, limit formulation operators to pumping out (b)(4), require employees to (b)(4), and (b)(4) on the new task instructions. You did not provide updated procedures, task instructions, or training records. We will verify implementation of any corrective actions during FDA’s next inspection of your facility.
Misbranding
Under section 201(qq) of the Act [21 U.S.C. § 321(qq)], soy is considered a “major food allergen”. 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 Plant Based Ranch 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 a major food allergen (soy).
Additional Comments
Your facility is subject to the requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP and PC rule) (21 CFR Part 117). As such, you are required to identify and implement preventive controls 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 facilities will not be adulterated under section 402 or misbranded under section 403(w) of the Act (21 CFR 117.135(a)(1) and (c)(2)). 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) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)].
The violations cited in this letter are not intended to be an all‐inclusive list of violations that exist in connection with your marketed 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 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 address these violations may result in enforcement 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, you should explain the reason for your delay and state when you will correct any remaining violations.
Your firm’s response should be sent to Katie Cutajar, Compliance Officer, via e-mail at Kathryn.Cutajar@fda.hhs.gov. If you have any questions about this letter, please contact Katie Cutajar at (313) 680-6962 or via e-mail.
Sincerely,
/S/
William R. Weissinger, MS
Program Division Director
Office of Human and Animal Food Operations
Division East 6
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