WARNING LETTER
Caribbean Produce Exchange, LLC
MARCS-CMS 679804 —
November 04, 2024
Delivery Method:
VIA EMAIL AND UNITED PARCEL SERVICE
Product:
Food & Beverages
Recipient:
Recipient Name
Felix Lopez
Recipient Title
General Manager
Caribbean Produce Exchange, LLC
Carr 869 Km 2.8 Interior
Las Palmas Industrial Park
Catano
,
PR
00962
United States
Issuing Office:
Division of Southeast Imports
United States
Secondary Issuing Offices
United States
November 4, 2024
WARNING LETTER
Dear Mr. Felix Lopez:
On February 27 through March 6, 2024, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) Inspection of Caribbean Produce Exchange, LLC located at Carr 869 Km 2.8 Interior, Las Palmas Industrial Park, Catano, PR 00962. 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-veriflcation-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. of Ecuador (Austrofood). 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 ready-to-eat (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 Apple Cinnamon Fruit Puree pouches from your foreign supplier, Austrofood. We acknowledge you were aware of the recall on November 2, 2023, before receiving the products on November 30, 2023, and quarantined and destroyed the product under FDA supervision on December 7, 2023. FDA placed apple cinnamon fruit puree pouches from your foreign supplier on Import Alert #99-42, "Detention Without Physical Examination (OWPE) 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.
At the conclusion of our inspection, our investigator provided you with a Form FDA 483a, FSVP Observations. We received your response to the FDA 483a, on March 19, 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 meet the requirement 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 pesticide residues), and physical hazards (21 CFR 1.504(b)(l)). 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)). Although you may meet your requirement to determine whether there are any hazards requiring a control by reviewing and assessing the hazard analysis conducted by another entity using a qualified individual, you must document your review and assessment of that hazard analysis, including documenting that the hazard analysis was conducted by a qualified individual (21 CFR 1.504(d)). Specifically, during our Inspection you did not have a written hazard analysis for the WanaBana apple cinnamon puree product you import from your foreign supplier, Austrofood.
We acknowledge receipt of your written response elated March 19, 2024. In your response, you described your food safety plan and approach to your risk analysis for "innovation products" which we understand to include apple cinnamon puree products from Austrofood, Ecuador. We also acknowledge that you provided your "FSVP Food Hazard Analysis" for Wanabana Apple Cinnamon Puree," which identifies the chemical hazard of "Presence of heavy metals like lead," as well as biological and physical hazards. You also indicated the chemical hazards required a control by your supplier through "supply chain" and by your company through a "supply chain program." You describe the nature of the control as being a supplier approval process of external suppliers and with results of analysis of the product. You also stated that you stopped purchases of this product and to continue, a "COA will be requested for each lot purchased." We will continue assessing the adequacy of your corrective actions and verification activities at our next inspection. Should you resume importing apple cinnamon puree products in the future, you will need to comply with all applicable FSVP regulations. including those described above.
2. You did not approve your foreign supplier on the basis of an evaluation of the foreign supplier's performance and the risk posed by the food, conducted in accordance with 21 CFR 1.506(a), and document your approval, as required by 21 CFR 1.505(b). During our inspection you provided your SOP for the approval of foreign suppliers, Document No. SOP-UC-00001 "Procedure for the Approval of Suppliers of Produce and Innovation Products" with an effective date before the recall of June 19, 2023, and an emailed link to the documents listed under Section 7.3.2 Foreign Suppliers related to your supplier, Austrofood However, you did not document your evaluation of your foreign supplier, Austrofood, as required under 21 CFR 1.505{a)(2) or that you approved them based on a review and assessment of the risk posed by the WanaBana Apple Cinnamon Fruit Puree pouches you Import.
In your written response dated March 19, 2024, you stated "review and assessment of the risk posed by the Apple Cinnamon Fruit Puree was conducted. The approval of Austrofood S.A.S has been documented" and you provided a copy of that form. You stated that your approval was based on "performance, the risk posed by a food and a review and assessment of their
(b)(4)
audit evaluation." You also added that "Austrofood S.A.S continues as an Approved Supplier but not the Apple Cinnamon Fruit Puree product. Austrofood S.A.S company needs to provide us with the HACCP and implemented controls for the associated risk." During our inspection you told our investigator you will continue to import other products such as fruit purees and smoothies from your foreign supplier Austrofood. We note your approval after the recall dated 3/19/2024 of Austrofood indicates they are approved with exceptions with the comment, "Supplier Approved for products with no cinnamon in their ingredients." We will assess the adequacy of your corrective actions at your next inspection.
3. 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). During our inspection, you told our investigator that your foreign supplier verification activity for your supplier Austrofood was a
(b)(4)
onsite audit report, and you provided an audit report with a start date of October 23, 2023 and a conclusion date of October 25, 2023. Upon request, you also provided the previous onsite audit report that was conducted for your supplier, Austrofood, from November 8, 2022 to November 10, 2022. Both onsite audits report a general scope of the audit performed that covers the WanaBana Apple Cinnamon Fruit Puree pouches. The onsite audit reports appear to include a review of the food safety plan and HACCP for your supplier Austrofood. However, you did not document your review and assessment of the audit reports or explain whether the onsite audit results provide adequate assurance that the biological, chemical and/or physical hazards requiring a control for the WanaBana Apple Cinnamon Fruit Puree pouches you Imported from Austrofood were significantly minimized or prevented.
In your written response dated March 19, 2024, you stated that you re-evaluated the
(b)(4)
onsite audit report dated October 24, 2023 to October 26, 2023 on March 18, 2024, and you provided your written evaluation. Based on this re-evaluation, you stated that you will continue to approve Austrofood as an approved foreign supplier, however for the WanaBana Apple Cinnamon Fruit Puree pouches, the audit did not present adequate assurance that the biological, chemical and/or physical hazards are being controlled. During our Inspection you told our investigator you will continue to import other products such as fruit purees and smoothies from your foreign supplier Austrofood However, per 21 CFR 1.506 (e)(1)(i), an onsite audit report conducted as a verification activity for food that is subject to one or more FDA food safety regulations must consider such regulations and include a review of the supplier's written food safety plan, if any, and its Implementation, for the hazard being controlled. As mentioned above, while the audit reports you list as part of your evaluation of your foreign supplier's approval mentioned a review of the FSP they did not Include a review of the supplier's implementation of their food safety plan, for the hazard being controlled, I.e., their practices and procedures regarding preventive controls requirements under 21 CFR part 117, specifically related to the identification and evaluation of the potential chemical hazards, including lead, or supply chain controls for your WanaBana Apple Cinnamon Fruit Puree pouches.
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.
You should take prompt action to address the above violations. If you do not promptly address them, we may take further action. For instance, we may take action under section 801(a)(.3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of the food you import which appear to be ln violation of section 805. We may place the food you import into the United States on detention without physical examination IDWPE) when you import the foods. You can find DWPE information relating to FSVP in Import Alert #99-41, "Detention Without Physical Examination (DWPE) of Human and Animal Foods Imported from Foreign Suppliers by Importers Who Are Not in Compliance with the Requirements of the Foreign Supplier Verification Program (FSVP) Regulation," 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.
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 CMSII 679804 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
Content current as of:
12/10/2024
Regulated Product(s)
Food & Beverages