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  5. Green Day Produce, Inc. - 679085 - 07/11/2024
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WARNING LETTER

Green Day Produce, Inc. MARCS-CMS 679085 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
William Chy
Recipient Title
Owner/Operating Officer
Green Day Produce, Inc.

5801 Alcoa Ave
Vernon, CA 90058-2026
United States

Issuing Office:
Division of West Coast Imports

United States

July 11, 2024

WARNING LETTER

Re: CMS # 679085

Dear Mr. Chy:

On February 7 through February 12, 2024, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Green Day Produce, Inc. located at 5801 Alcoa Ave., Vernon, CA. We also conducted inspections on August 24, 2023 and February 9, 2023. 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 following foods you import:

  • Seafood Mushrooms imported from (b)(4)
  • Oyster Mushrooms imported from (b)(4)
  • Taiwanese Mangos imported 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 acknowledge receipt of your response date February 27, 2024, and we address your response below.

Your significant violations of the FSVP regulation are as follows:

1. You did not evaluate your foreign supplier’s performance and the risk posed by the foods you import, including the foreign supplier’s compliance with applicable FDA food safety regulations and information relevant to the foreign supplier's compliance with those regulations, in accordance with 21 CFR 1.505(a)(1)(iii).

Specifically, you did not evaluate your foreign suppliers of covered produce for compliance with the Produce Safety Rule (PSR), 21 CFR part 112. During our inspection, you provided FSVPs for your seafood mushrooms and oyster mushrooms imported from (b)(4) and for your (b)(4) mangos imported from (b)(4). Seafood mushrooms, oyster mushrooms, and mangos are “covered produce” as defined in 21 CFR 112.3, and therefore must comply with FDA’s Standards for Growing, Harvesting, Packing and Holding of Produce for Human Consumption (Food Safety Modernization Act (FSMA) Produce Safety Rule) regulation. You provided a document identified as “Produce Safety Rule and FSVP Standards”. However, this document provides definitions and general procedures, and it does not demonstrate your evaluation of your foreign supplier’s performance and the risk posed by the foods you import, including applicable FDA food safety regulations.

In addition, other FSVP documents you provided do not adequately demonstrate that you considered your foreign supplier’s performance and risk posed by the foods you import. In your written response dated February 27, 2024, you provided documents identified as “Supplier FSVP Verification” for oyster and seafood mushrooms from (b)(4) and a “Supplier Risk Assessment” for (b)(4) mangos from (b)(4). These documents describe the business activity of (b)(4) as “selling and labelling goods to domestic market and foreign market” and the business activity of (b)(4). as a “packhouse”. We note that these entities do not appear to meet the definition of a foreign supplier. A foreign supplier is the establishment that manufactures/processes the food, raises the animal, or grows the food that is exported to the United States without further manufacturing/processing by another establishment, as defined in 21 CFR 1.500.

2. Your supplier verification activities did not provide adequate assurance that the hazards requiring a control in the foods you import have been significantly minimized or prevented, as required by 21 CFR 1.506(c).

Specifically, for your oyster mushrooms and seafood mushrooms from (b)(4) you provided a third-party audit report identified as “(b)(4) audit report” ((b)(4)). Your oyster and seafood mushrooms are “covered produce” under FDA’s produce safety regulation (as defined in 21 CFR 112.3), however, the third-party audit of (b)(4) did not consider whether your foreign supplier follows the procedures set forth in that regulation to significantly minimize or prevent biological hazards in the covered produce.

In your written response dated February 27, 2024, you provided a document identified as “Food Safety Plan for Produce Supply Chain at Green Day Inc.”, created in August 2023. We are unable to evaluate the adequacy of your response. We note that this document appears to provide a general hazard analysis and other standards pertaining to your importation of produce and it does not describe particular products or foreign suppliers of those products.

You import fresh produce that is “covered produce” as defined in 21 CFR 112.3. As an importer of covered produce, you must have an FSVP that demonstrates that your 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 419 of the FD&C Act (21 U.S.C. 350h) (regarding standards for produce safety) and the implementing regulations in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (21 CFR part 112).

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.

In addition, we offer the following comment:

  • We acknowledge your corrective action to (b)(4) importation of enoki mushrooms from the foreign supplier, (b)(4). If you choose to resume importing from this supplier in the future, you are required to re-evaluate the foreign supplier's performance and the risk posed by a food as required by 21 CFR 1.505. In addition, it is your responsibility to promptly reevaluate your suppliers when you become aware of new information concerning your foreign suppliers’ performance and the risk posed by a food, and the reevaluation must be documented.

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 from the identified foreign suppliers 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)).

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 revised 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: Dan Simonsen, Compliance Officer
Division of West Coast Imports
1 World Trade Center, Ste. 300
Long Beach, CA 90831

If you have any questions regarding this letter, you may contact Compliance Officer Dan Simonsen via email at Daniel.Simonsen@fda.hhs.gov. Please reference CMS # 679085 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.

Sincerely,
/S/

Dr. Kathleen Turner
Program Division Director
Division of West Coast Imports

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