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  5. WANABANA USA LLC - 680548 - 11/04/2024
  1. Warning Letters

WARNING LETTER

WANABANA USA LLC MARCS-CMS 680548 —

Delivery Method:
VIA EMAIL AND UNITED PARCEL SERVICE
EXPRESS DELIVERY SIGNATURE REQUEST
Product:
Food & Beverages
Recipient:
Recipient Name
Francisco Pena Cordovez
Recipient Title
President
WANABANA USA LLC

2113 W. 30th St.
Jacksonville, FL 32209-3634
United States

Issuing Office:
Division of Southeast Imports

United States

Secondary Issuing Offices

United States

WARNING LETTER

November 4, 2024

Re: CMS # 680548

Dear Mr. Francisco Pena Cordovez:


On February 21 through March 7, 2024, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of WanaBana USA LLC located at 2113 W. 30th St., Jacksonville, FL 32209-3634. This inspection was conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1, subpart L. The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA's FSVP web page at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.

During the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1, subpart L for the foods you import. Because of these significant violations, your firm is not in compliance with section 805 of the FD&C Act.

The inspection was initiated in response to a multistate investigation involving elevated levels of lead in apple cinnamon fruit puree pouches (intended for infants as young as six months and the general public), manufactured by your foreign supplier Austrofood S.A.S. (Austrofood) of Ecuador. Apple cinnamon fruit puree pouches were subject to a Class 1 recall, initiated on October 29, 2023. The recall was in response to finished product samples of Wanabana brand RTE apple cinnamon fruit puree packed in flexible pouches, collected by North Carolina Department of Health and Human Services (NCDHHS) found to contain extremely high concentrations of lead. You imported Wanabana brand apple cinnamon fruit puree pouches from your foreign supplier, Austrofood. We placed apple cinnamon fruit puree pouches from your foreign supplier on Import Alert #99-42, "Detention Without Physical Examination (DWPE) of Foods Due to Heavy Metal (Toxic Element) Contamination," on November 6, 2023. You may view this alert at: https://www.accessdata.fda.gov/cms_ia/importalert_1167.html.

FDA and state partners also collected and analyzed additional product samples of fruit puree and apple sauce pouches manufactured by your foreign supplier Austrofood. FDA, the Maryland Department of Health (MDH), and the North Carolina Department of Agriculture & Consumer Services (NCDA&CS) detected extremely high concentrations of lead in WanaBana Apple Cinnamon Fruit Puree pouches imported by your firm. FDA has reviewed and supports the MDH and NCDA&CS analytical findings. Specifically: 

■ 2.18 parts per million (ppm) lead was detected in FDA Sample 1234871, 6.43 ppm lead was detected in MDH Sample FC2400004901, and 2.16 - 3.19 ppm lead was detected in NCDA&CS Samples FDC0222755 - FDC0222760 of WanaBana Apple Cinnamon Fruit Puree pouches collected from Dollar Tree stores.

At the conclusion of the inspection, our investigator provided you with a Form FDA 483a, FSVP Observations. We have received your response to the FDA 483a, issued on March 20, 2024, describing corrective actions taken and planned by your firm and we address your response below.

Your significant violations of the FSVP regulations are as follows:

1. You did not conduct a hazard analysis to identify and evaluate, based on experience, illness data, scientific reports, and other information, known or reasonably foreseeable hazards for each type of food you import to determine whether there are any hazards requiring a control for the apple cinnamon puree product you import from your foreign supplier, Austrofood, per 21 CFR 1.504(a). The analysis of the known or reasonably foreseeable hazards in each food must include biological hazards, chemical hazards (including pesticide residues), and physical hazards (21 CFR 1.504(b)(1)). Specifically, your hazard analysis for your fruit purees and smoothies from your foreign supplier, Austrofood did not identify and evaluate the potential chemical hazard of heavy metals, specifically lead, to determine whether the hazard requires a control per 21 CFR 1.504(a).

During our inspection you provided our investigator with your "FSVP Program Version 1" dated September 8, 2021 for your fruit purees and smoothies noting intended consumers as "general public aged over 12 months" and which included your hazard analysis. Your hazard analysis did not consider the chemical hazard of heavy metals, specifically lead, as a potential food safety hazard for the apple cinnamon fruit puree you import from your foreign supplier, Austrofood. Subsequently, you did not consider this hazard when evaluating your foreign supplier or determining appropriate verification activities for the foods you imported from your foreign supplier, which were subject to the recall that was initiated October 29, 2023.

During our inspection you also provided your revised FSVP including your hazard analysis dated January 10, 2024, for your apple cinnamon fruit puree from your foreign supplier, Austrofood. You also provided a written response, which we received on May 6, 2024, in which you submitted your FSVP Version 3 for Fruit and vegetable purees in a pouch from Austrofood; an FSVP record #1, Foreign Supplier Hazard Analysis Review and Evaluation, dated April 10, 2024; and FSVP record #3, Foreign Supplier Verification Activity(s), dated April 10, 2024. We acknowledge that your revised hazard analysis dated January 10, 2024, and your revised hazard analysis provided in your May 6, 2024, response both identified the chemical hazard of "heavy metals (arsenic, lead, chromium, cadmium, copper)" as a potential hazard in your fruit and vegetable purees in a pouch. These revisions were dated after you imported these foods from your foreign supplier and after FDA found high levels of lead in your apple cinnamon puree imported from your supplier, Austrofood, S.A.S. We will continue assessing the adequacy of your corrective actions and verification activities at our next inspection.

2. Your foreign supplier verification activities did not provide assurance that the hazards requiring a control in the food you import have been significantly minimized or prevented, as required by 21 CFR 1.506(c). You did not, based on the determination made in accordance with 21 CFR 1.506(d), conduct and document, or obtain documentation of, one or more of the supplier verification activities listed in 21 CFR 1.506(e)(1)(i) through (iv) for each foreign supplier before importing the food and periodically thereafter, as required by 21 CFR 1.506(e).

During our inspection you provided your FSVP, dated August 9, 2021, for your apple cinnamon puree from foreign supplier, Austrofood. You told our investigator that this was the FSVP you implemented for the products you imported prior to the Class 1 recall initiated in October 2023. Your FSVP included your six-page "Form 3 - FSVP Supplier Verification Activity Form" which shows that you determined your verification activities to be a "3rd party audit" and a Review of (b)(4) relevant to food safety" conducted (b)(4) (page 3). You also provided the audit report (10/18/2021-10/20/2021) referenced in your onsite audit review (page 4) and the Quality Certificate (not dated) referenced in your "Review of food safety records" (page 5). Your approval is dated 10/10/2022 (page 6). You also provided a (b)(4) audit of your supplier, Austrofood from 2023. However, prior to importing your apple cinnamon puree in February 27, 2023, you did not conduct and document your supplier verification activity, specifically (b)(4) audit of your foreign supplier in 2022 as required by as required by 21 CFR 1.506(e). Additionally, the Quality Certificate and translation you provided shows testing results for samples of the cinnamon powder used by your foreign supplier. This record of sampling and testing includes results for heavy metals arsenic(<1.0 mg/kg) and lead (<2.0 mg/kg) but does not include the test(s) conducted (including the analytical method(s) used), the date(s) on which the test(s) were conducted, or the date of the report of the testing, as required by 21 CFR 1.506(e)(1)(ii). You imported your apple cinnamon puree from Austrofood based on the FSVP records described above, a product which was subsequently subject to a Class 1 recall in October 2023.

We acknowledge that you provided your Form #4 FSVP Supplier Reevaluation form for Austrofood S.A.S. in your Form 483a response dated April 10, 2024, and you stated that your current verification activities included Laboratory analysis of heavy metals for (b)(4) of finished product that contains spices as ingredients. While you provided a Quality certificate for cinnamon, as described above, you have not provided records or documentation of heavy metal analysis in the finished product of apple cinnamon puree.

3. You must promptly reevaluate a foreign supplier's performance or the risk posed by a food when you became aware of new information about the foreign supplier's performance or the risk posed by a food, as required by 21 CFR 1.505(c)(1). If you determine that the concerns associated with importing a food from a foreign supplier have changed, you must promptly determine (and document) whether it is appropriate to continue to import the food from the foreign supplier and whether the supplier verification activities conducted under § 1.506 need to be changed. However, you were notified in October 2023 of the hazard associated with your apple cinnamon puree imported from Austrofood S.A.S. but you did not conduct your reevaluation of your foreign supplier until January 2024, over 3 months later. Furthermore, you provided your "Form #4 Supplier Reevaluation on which you indicate "The foreign supplier passed the most recent third-party food safety audit (include score, results and date)." This is followed in part by "GSFI, (b)(4)" and "FDA Audit - 4 nonconformities, 12/4/2024 to 12/13/2024." Your assessment in your January 16, 2024 reevaluation of your supplier shows that you relied on the (b)(4) Audit (October 24-26, 2023), which was conducted before you became aware of the recall on October 27, 2023 (per your statements during the inspection) and before corrections would have been made by the foreign supplier, Austrofood S.A.S. Additionally, your assessment did not appropriately consider the FDA inspection conducted at Austrofood S.A.S, which resulted in four non-conformities on December 14, 2023, after the Class I Recall. FDA finds your reevaluation was neither conducted promptly, nor was your determination to continue with importing apple cinnamon puree from Austrofood S.A.S appropriate.

We acknowledge in your written response dated May 6, 2024 that your updated Procedure for reevaluating activities of foreign suppliers states that you will re-evaluate a foreign supplier within (b)(4) if the foreign suppler is associated with a "recall, import alerts, etc." The adequacy of this corrective action will be verified at the next inspection.

The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1, subpart L.

This letter notifies you of our concerns and provides you an opportunity to address them. If you do not adequately address this matter, we may take further action. For instance, we may take action under section 80l(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of the food you import for which you appear to be in violation of section 805. We may place the foods you import into the United States on detention without physical examination (DWPE) when you import the foods. You can find DWPE information relating to FSVP in Import Alert #99-41 at http://www.accessdata.fda.gov/cms_ia/ialist.html. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act (21 U.S.C. 331(zz)).

Additionally, we offer the following comment:

You are required to conduct a written hazard analysis for each type of food you import to determine whether there are any hazards requiring a control, as required by 21 CFR 1.504. A hazard analysis must identify known or reasonably foreseeable hazards for each type of food you import to determine whether there are any hazards requiring a control (21 CFR 1.504(a)). The analysis of the known or reasonably foreseeable hazards in each food must include biological hazards, chemical hazards (including heavy metals, such as lead), and physical hazards (21 CFR 1.504(b)(1)). Your hazard analysis must include an evaluation of the identified hazards to assess the probability that the hazard will occur in the absence of controls and the severity of the illness or injury if the hazard were to occur (21 CFR 1.504(c)(1)). Your hazard analysis must be written regardless of its outcome, in accordance with 21 CFR 1.504(a). Your hazard analysis must also include known or reasonably foreseeable hazards that may be present in a food if it the hazard occurs naturally, if the hazard is unintentionally introduced, or if the hazard may be intentionally introduced for purposes of economic gain, per 21 CFR 1.504(b)(2). Finally, your hazard evaluation must also consider, among other things, the formulation of the food, the raw materials and other ingredients, and any other relevant factors on the safety of the finished food for the intended consumer.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct any violations. You should include in your response documentation and information that would assist us in evaluating your corrections, (e.g., documentation of changes you made, such as a copy of your FSVP, records to demonstrate implementation of your FSVP), and any additional information that you wish to supply relevant to your compliance with the FSVP regulation. If you believe that you are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrections within 15 working days, you should explain the reason for your delay and state when you will correct any remaining violations.

Please send your reply to Food and Drug Administration, Attention: Allison McGloin, Compliance Officer, Division of Southeast Imports, 550 Main Street, Suite #4-930, Cincinnati, OH 45202. If you have any questions regarding this letter, you may contact Compliance Officer Allison McGloin via email at Allison.McGloin@fda.hhs.gov. Please reference CMS# 680548 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.

Sincerely,
/s/
Ruth Dixon
Program Division Director
Division of Southeast Imports

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