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WARNING LETTER

Eco Food Distribution, LLC MARCS-CMS 656345 —


Delivery Method:
Via Express Delivery
Product:
Food & Beverages

Recipient:
Recipient Name
Dorothy (NMI) Ziaja
Eco Food Distribution, LLC

3900 River Rd Rear B
Schiller Park, IL 60176-2356
United States

Issuing Office:
Division of Northern Border Imports

United States


May 25, 2023

WARNING LETTER

Re: CMS #656345

Dear Dorothy Ziaja:

On February 28 through March 29, 2023, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Eco Food Distribution, LLC, 3900 River Rd Rear B Schiller Park, IL 60176-2356. We also conducted an inspection on July 02, 2019 and on July 12, 2022. These inspections were 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 from the foreign suppliers indicated in the attached list and for the chocolate-covered gingerbread apple you import from (b)(4) located in (b)(4), and the carrot nectar you import from (b)(4) located in (b)(4). Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.

At the conclusion of the inspection, our investigator provided you with a Form FDA 483a FSVP Observations. To date, we have not received your response.

Your significant violations of the FSVP regulation are as follows:

1. You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, you did not develop an FSVP for the foods you import from the foreign suppliers indicated in the attached list.

2. You did not 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. Specifically, for the chocolate-covered gingerbread apple you import from (b)(4) and the carrot nectar you import from (b)(4), you did not provide a written hazard analysis to identify and evaluate known or reasonably foreseeable hazards for the food you import to determine whether there are any hazards requiring a control, as required by 21 CFR 1.504.

3. You did not approve your foreign suppliers based on an evaluation of the foreign supplier’s performance and the risk posed by the food, conducted in accordance with 21 CFR 1.505(a), and document your approval, as required by 21 CFR 1.505(b). Specifically, for the chocolate-covered gingerbread apple you import from (b)(4) and the carrot nectar you import from (b)(4), you did not provide documentation that you have evaluated your foreign supplier’s performance and risk posed by the food, as required by 21 CFR 1.505(a), or your approval of these suppliers, as required by 21 CFR 1.505(b).

During the inspection, you provided documents to the investigator, including a document titled, “FSVP Protocol,” which describes that, for the food you import, you have the foreign manufacturers provide either a certificate of safety, a document showing the process of how the food is produced, and/or a document of an audit or inspection of their facility concluding the food is produced properly. This document also states that if the manufacturer provides “a procedure that lacks safety” or if the manufacturer “has failed a safety inspection and/or is on a violations list,” you will not import from them. However, you did not provide any documentation demonstrating your implementation of these procedures, including with respect to your evaluation of the chocolate-covered gingerbread apple you import from (b)(4) and the carrot nectar you import from (b)(4). You also provided the following documents: for your carrot nectar imported from (b)(4), a process flow chart from your foreign supplier; and, for your chocolate-covered gingerbread apple imported from (b)(4), a certificate saying your foreign supplier’s “Food Safety Management System . . . has been assessed and found to be in accordance with the requirements of: ISO 22000:2018.” While these documents may be part of what you consider in your evaluation of your foreign supplier’s performance and the risk posed by a food, they do not cover all the factors you must consider under 21 CFR 1.505(a)(1). Moreover, you did not document your review and assessment of the process flow chart or the certificate, nor did you document any other evaluation of your foreign suppliers’ performance and the risk posed by the food, or approval of these foreign suppliers, as required by 21 CFR 1.505(a) and 1.505(b), respectively.

4. You did not perform foreign supplier verification activities in accordance with 21 CFR 1.506. Specifically, for the chocolate-covered gingerbread apple you import from (b)(4) and the carrot nectar you import from (b)(4), you did not determine and document which verification activity or activities, as well as the frequency with which the activity or activities must be conducted, are needed to provide adequate assurances that the food you obtain from the foreign supplier is produced in accordance with 21 CFR 1.506(c), as required by 21 CFR 1.506(d). In addition, you did not 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 of these foreign suppliers before importing these foods and periodically thereafter, as required by 21 CFR 1.506(e).

With respect to the requirements of 21 CFR 1.506(e), while you may rely on supplier verification activities conducted in accordance with 21 CFR 1.506(e)(1) by another entity, you must promptly review and assess the results of the verification activities conducted by another entity and document your review and assessment (21 CFR 1.506(e)(3)). In addition, for an onsite audit, you must retain documentation of each onsite audit, including the audit procedures, the dates the audit was conducted, the conclusions of the audit, any corrective actions taken in response to significant deficiencies identified during the audit, and documentation that the audit was conducted by a qualified auditor (21 CFR 1.506(e)(1)(i)(D)). For food that is subject to one or more FDA food safety regulations, an onsite audit of the foreign supplier 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 (21 CFR 1.506(e)(1)(i)(B)). The certificate for your foreign supplier (b)(4) does not include audit procedures; it also does not indicate that they assessed compliance with FDA food safety regulations, reviewed the supplier’s written food safety plan, or were conducted by a qualified auditor. Further, you did not provide any documentation showing that you reviewed and assessed the results of this audit. For the carrot nectar you import from (b)(4), you did not provide any documentation that you have conducted and documented (or obtained documentation of) one or more of the supplier verification activities listed in 21 CFR 1.506(e)(1)(i) through (iv).

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 801(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 from the identified foreign suppliers 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)).

In addition, we offer the following comment:

We note that you may meet the definition of a “very small importer” under 21 CFR 1.500. If you meet the definition, you are still required to follow FSVP requirements. If you are a very small importer and you choose to comply with the modified requirements in 21 CFR 1.512 for very small importers, you must document that you meet the definition of a very small importer as required per 21 CFR 1.512(b)(1)(i) and you also are required to comply with the requirements in sections 1.502, 1.503, and 1.509; however, you are not required to comply with the requirements in sections 1.504 through 1.508 or 1.510 (see 21 CFR 1.512(b)(2)). In addition, for each food you import, you must obtain written assurance, before importing the food and at least every two years thereafter, that your foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 of the FD&C Act, if either is applicable, and the implementing regulations, and is producing the food in compliance with sections 402 and 403(w) (if applicable) of the FD&C Act (see 21 CFR 1.512(b)(3)(i)).

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: Alyssa Wenke, Compliance Officer, Division of Northern Border Imports, at Alyssa.Wenke@fda.hhs.gov. If you have any questions regarding this letter, you may contact CO Wenke via email. Please reference CMS #656345 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/

Keith J. Jasukaitis
Program Division Director
Division of Northern Border Imports

CC: Jacob R. Ziaja , Owner
Eco Food Distribution, LLC.
3900 River Rd Rear B
Schiller Park, IL 60176-2356

 
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