WARNING LETTER
Greenfruit Avocados, LLC
MARCS-CMS 679532 —
July 08, 2024
Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Brian E. Gomez
Recipient Title
CEO/President
Greenfruit Avocados, LLC
20371 Irvine Ave Ste 200
Newport Beach
,
CA
92660-0251
United States
Issuing Office:
Division of West Coast Imports
United States
July 08, 2024
WARNING LETTER
Re: CMS # 679532
Dear Mr. Brian E. Gomez:
On January 16, 2024, through January 18, 2024, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Greenfruit Avocados LLC., located at 20371 Irvine Ave Ste 200, Newport Beach, CA 92660-0251. We also conducted inspections from August 21, 2020, to September 29, 2020, and from May 9, 2023, to June 6, 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-supplierverification-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
(b)(4)
Avocados you import. 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 responses on February 9, 2024, February 27, 2024, and March 4, 2024, in which you described your corrective actions for the observations listed on the 483a and submitted FSVP records referenced in your response. We address your response below.
Your significant violations of the FSVP regulation are as follows:
1. You did not approve your foreign suppliers based on an evaluation of your 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). You did not consider the entities controlling the hazard as required under 21 CFR 1.505(a)(1)(ii) or the foreign supplier's performance including applicable FDA food safety regulations and information relevant to the foreign supplier’s compliance with those regulations, per 21 CFR 1.505(a)(1)(iii). Specifically, you import avocados which are raw agricultural commodities covered under 21 CFR Part 112, Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (the Produce Safety Rule). FDA has determined that the biological hazards in covered produce require a control, and compliance with the requirements in the Produce Safety Rule significantly minimizes or prevents the biological hazards. However, your supplier verification activities did not include evaluating the growers’ performance with the Produce Safety Rule for the covered produce you import, including, but not limited to the following products:
(b)(4)
Avocados obtained from the packer,
(b)(4)
.
(b)(4)
Avocados obtained from the packer,
(b)(4)
.
(b)(4)
Avocados obtained from the packer,
(b)(4)
.
(b)(4)
Avocados obtained from the packer,
(b)(4)
.
During our most recent inspection you told our investigator you did not know the identity or evaluate the growers of the avocados you obtain from the packers. You refer to the packers as your suppliers and explained that your FSVP considered only the packers. The FSVP regulation defines “foreign supplier” as, for an article of food, 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, except for further manufacturing/processing that consists solely of the addition of labeling or any similar activity of a
de minimis
nature, per definition in 21 CFR 1.500. Here, the foreign supplier is the grower(s) of the avocados. The packers and packing houses you have been working with perform activities of a de minimis nature and are not foreign suppliers, as defined by the FSVP regulation. You provided documents from the packers which you said you reviewed, including, but not limited to, HACCP plans, 3rd party audits, pesticide controls and testing, and laboratory results for water and micro-organisms. You also provided your hazard analyses for the foods you import. You explained that your evaluation and approval of the packers did not include a review of the growers of the fresh avocado. The third-party audits and certificates, some of which are not in English, you provided for the packers,
(b)(4)
, and
(b)(4)
, described the entities being audited as packing houses and were conducted on post-harvest operations.
Your responses on February 9, 2024, February 27, 2024, and March 4, 2024, included documentation related to packing houses, however they did not include any of the FSVP required information for the growers of the avocados. Your response also did not address how you are evaluating the growers of your fresh avocado. The records you provided related to the packers may be used to assist you to comply with the FSVP regulation, such as when making a determination of appropriate foreign supplier verification activities per 21 CFR 1.506(d) and such verification activities must address the entity or entities that are significantly minimizing or preventing the hazards or verifying that the hazards have been significantly minimized or prevented (e.g., when an entity other than the grower of produce subject to 21 CFR part 112 harvests or packs the produce and significantly minimizes or prevents the hazard or verifies that the hazard has been significantly minimized or prevented), per 21 CFR 1.506(d)(1)(i).
2. You did not establish and follow written procedures to ensure that you import foods only from foreign suppliers you have approved 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, and document your use of these procedures, as required by 21 CFR 1.506(a)(1). While you may rely on an entity other than your foreign supplier to establish the procedures and perform and document the activities required under 21 CFR 1.506(a)(1), you must review and assess that entity’s documentation of the procedures and activities, and you must document your review and assessment, as required by 21 CFR 1.506(a)(2). Specifically, you did not establish written procedures to ensure that you import foods only from approved foreign suppliers, specifically the growers of the fresh avocados, as required by 21 CFR 1.506(a)(1).
Your responses received on February 9, 2024, February 27, 2024, and March 4, 2024, included documentation of procedures for the evaluation and approval of foreign suppliers, but you did not follow these written procedures to ensure that you import foods only from foreign suppliers you have approved nor did you document your use of these procedures. The FSVP SOP you submitted contains written procedures for the evaluation and approval of foreign suppliers. However, you have previously explained that your evaluation and approval did not include a review of the growers of the fresh avocado, which are the foreign suppliers. You explained that you completed the “Foreign supplier verification” and “Foreign Supplier Activities” forms for each of the packing houses, which you referred to as your suppliers. You further stated that each supplier submits requested documents and is then assessed by you for FDA recalls, import alerts, warning letter, and other outstanding issues with regards to importing product and food safety. You give each supplier a “yes” or “no” approval and all suppliers are currently approved and will be assessed on a
(b)(4)
basis. Your evaluation and approval procedures did not ensure you import avocado only from foreign suppliers you have approved, as required by 21 CFR 1.506(a)(1). As previously stated, the growers of the fresh avocado are the foreign suppliers, per 21 CFR 1.500). For purposes of the FSVP regulation, the packers and packing houses are not foreign suppliers.
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 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)).
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. Please provide an English translation of any records that you provide in a language other than English in order to facilitate our review. 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: Lin Liu, Compliance Officer, Division of West Coast Imports, One World Trade Center, Suite 300, Long Beach, CA 90831, with a copy via electronic email to WCID@FDA.HHS.GOV. If you have any questions regarding this letter, you may contact Mr. Lin Liu via email at lin.liu@fda.hhs.gov. Please reference CMS #679532 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.
Sincerely,
/S/
Kathleen Turner, DVM
Program Division Director
Division of West Coast Imports
Content current as of:
07/23/2024
Regulated Product(s)
Food & Beverages