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October 21, 2021

WARNING LETTER

Re: CMS # 616669

Dear Ms. Grace Hu:

On June 23 through June 29, 2021, the Food and Drug Administration (FDA) conducted a remote Foreign Supplier Verification Program (FSVP) inspection for Green Food Ingredients, LLC located at 1333 Burr Ridge, Pkwy Suite 200., Burr Ridge IL 60527-0833. We also conducted an inspection on April 24 through July 29, 2020. 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 were not in compliance with the requirements of 21 CFR part 1 subpart L for a food product that you import, including but not limited to, Roasted Garlic Powder you import from (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. We have not received your response to the Form FDA 483a issued on June 29, 2021.

Your significant violation of the FSVP regulation is as follows:

You did not meet the requirements to perform foreign supplier verification activities as required by the FSVP rule (21 CFR 1.506). Specifically, you did not establish written procedures for ensuring that appropriate supplier verification activities are conducted in accordance with 21 CFR 1.506(b), and you did not document your determination of the appropriate supplier verification activity or activities in accordance with 21 CFR 1.506(d). With respect to the requirements of 21 CFR 1.506(e), while you may rely on third-party food safety audits as part of your foreign supplier verification activities, you must ensure the audit is performed by a qualified auditor and that they assessed compliance with FDA food safety regulations (or, when applicable, an onsite audit may consider relevant laws and regulations of a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States). You must also promptly review and assess any third-party audit that constitutes a verification activity, as well as document your review and assessment, among other requirements (21 CFR 1.506(e)).

During the current inspection, you provided records for the Roasted Garlic Powder manufactured by (b)(4) which you said is the same company as (b)(4). These records included a kosher certificate, (b)(4) third-party audit certificates for FSMA Preventive Controls and (b)(4), and an FSPCA training certificate for FSMA Preventive Controls for Human Foods completed by an employee of (b)(4). To the extent you intended these third-party audit certificates to constitute a verification activity, you must promptly review and assess the results of the verification activity and document your review and assessment in accordance with 21 CFR 1.506(e)(3).

The above violation is 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. Failure to adequately address this matter may result in 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 products you import that appear to be in violation of section 805. We may place the food you import from the identified foreign supplier on detention without physical examination (DWPE). 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 to the above violation, we also have the following comment:

You must conduct a 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). Although you may meet this requirement 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)).

During the previous inspection in July 2020, you provided FDA records including an unidentified flow diagram, a hazard analysis from (b)(4), HACCP plan from (b)(4), and a (b)(4). You may meet your requirement to conduct a hazard analysis, as required under 21 CFR 1.504(a), by reviewing and assessing your supplier’s hazard analysis and documenting your review and assessment of that hazard analysis (21 CFR 1.504(d)). To the extent you intended to rely on these records to meet your obligations under the FSVP regulation, we note that you did not provide FDA any documentation of your review and assessment of these records or that the hazard analysis was conducted by a qualified individual. Lastly, the hazard analysis and HACCP plan provided were primarily in (b)(4). Per 1.510(b)(1), upon FDA request, you must provide within a reasonable time an English translation of records maintained in a language other than English.

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 will 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: Mark Kaspar, Compliance Officer, DNBI, USFDA, 550 W Jackson, 15th Floor Chicago IL 60661. If you have any questions regarding this letter, you may contact Mark Kaspar via email at [email protected]. Please reference CMS Case 616669 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