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May 14, 2024

WARNING LETTER

Re: CMS # 678393

Dear Ms. Tran,

On December 13, 2023, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Genpro Imports & Exports Inc., located at 7766 Industry Ave., Pico Rivera, CA 90660. We also conducted an inspection on May 11, 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 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 still not in compliance with the requirements of 21 CFR part 1, subpart L for the foods you import from the foreign suppliers noted below. 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 dated January 4, 2024 in which you provide a short written response to each observation and include several attached documents, including your (b)(4) Evaluation and Verification Form, (b)(4) Supplier Qualification Form and Evaluation, (b)(4) FSVP Evaluation Form, (b)(4) FSVP Foreign Supplier Verification Activity, and (b)(4) Hazard Analysis HACCP, HACCP Internal Audit. We address your response below.

Your significant violations of the FSVP regulations 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, including the following foods:

• Summer squash, eggplant, and bitter melon, imported from (b)(4), located in Mexico.

You import summer squash, which is “covered produce” as defined in 21 CFR 112.3. Your FSVP must demonstrate 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).

2. You did not 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). Specifically, during our inspection, you did not provide a written hazard analysis or any FSVP records for your fresh ginger from (b)(4) China. Subsequently, in your written response, dated January 4, 2024, you provided your Supplier Qualification Form and FSVP Foreign Supplier Evaluation Form for fresh ginger from (b)(4), in which you indicated that your foreign supplier did not provide a hazard analysis for ginger. In your written response, you also provided an attachment called “(b)(4) Hazard Analysis HACCP HACCP Internal Audit,” which you described as your written hazard analysis in response to the inspection observation that you did not conduct a hazard analysis for the ginger you import from (b)(4) China However, this document does not include a hazard analysis for the ginger you import from (b)(4) China. Specifically, this document includes your HACCP plan for “Wholesale Vegetables.” Part of your HACCP plan is a table titled “Safety Risk Assessment, and Preventive Controls for Fruit and Produce Storage” that lists “Likely Hazard” and “Control Measures” for the category “Fruits & Vegetables targeted at the general population including high-risk groups.” This table is followed by a chart listing related storage conditions for different types of produce, including ginger root. Your “(b)(4) Hazard Analysis HACCP HACCP Internal Audit” document states on page one, "the HACCP team will also take into consideration all potential hazards from the country of origin of all sourced products”; the countries of origins listed on the product descriptions in the HACCP plan are USA and Mexico, but not China. Thus, while you provided your HACCP plan with a hazard analysis for various produce from USA and Mexico, you did not document a hazard analysis for your ginger from (b)(4).

3. You did not approve your foreign suppliers on the basis of your evaluation of your foreign supplier’s performance and the risk posed by the food in accordance with 21 CFR 1.505(a), as required by 21 CFR 1.505(b). In addition, you did not establish and follow written procedures to ensure that you import foods only from foreign suppliers you have approved based on the evaluation conducted under 21 CFR 1.505, as required by 21 CFR 1.506(a)(1). Specifically, you did not approve your foreign supplier (b)(4), but you continued to import food from this foreign supplier. During the inspection, you told our investigator that you stopped importing from certain foreign suppliers, including (b)(4). Additionally, in your written response, dated January 4, 2024, you provided FSVP documents for your imported taro titled, “(b)(4) Evaluation and Verification Form.” These documents show that your foreign supplier did not provide any records that you requested, such as a hazard analysis. You documented on December 20, 2023 that the result of your foreign supplier evaluation was that you did not approve your foreign supplier. However, our records indicate that you continued to import taro, summer squash, eggplant, and bitter melon from (b)(4), Mexico in January and February 2024.

Furthermore, for your foreign supplier, (b)(4), you did not evaluate your foreign supplier’s performance and the risk posed by the food in accordance with 21 CFR 1.505(a). Under 21 CFR 1.505(a), you must consider the hazard analysis of the food, the entity or entities that would be significantly minimizing or preventing the hazards requiring a control or verifying that such hazards have been significantly minimized or prevented, the foreign supplier performance, and any other factors as appropriate and necessary. In your written response, dated January 4, 2024, you provided your Supplier Qualification Form and FSVP Foreign Supplier Evaluation Form for fresh ginger from (b)(4), in which you indicated that your foreign supplier did not provide a hazard analysis for ginger. As noted above, while you provided a hazard analysis for various produce from USA and Mexico, you did not document a hazard analysis for your ginger from (b)(4) China, as required by 21 CFR 1.504(a). Accordingly, your supplier evaluation did not consider a hazard analysis for ginger from supplier (b)(4)., conducted in accordance with 21 CFR 1.504, as required by 21 CFR 1.505(a)(1)(i).

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 from the foreign suppliers noted above 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:

With respect to foreign supplier verification activities, your response dated January 4, 2024 included several documents, including your FSVP Foreign Supplier Verification Activity for your ginger from (b)(4) China. This record documents your “Verification Activity and Frequency” as “Request Supplier Verification Form: (b)(4)” and “FDA website search for alerts: (b)(4) or when supplier is notified of alert.” It also documents your verification records as, “Global GAP Certificate,” “Supplier Qualification Form” and “Letter of Guarantee.” To the extent you intend the “Global GAP Certificate” to be a record of an onsite audit, you did not provide documentation of the onsite audit or otherwise document 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, or documentation that the audit was conducted by a qualified auditor. With respect to the requirements of 21 CFR 1.506(e) regarding the performance of foreign supplier verification activities, while you may rely on third-party food safety audits as part of your foreign supplier verification activities, 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)).

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: Sundy Sedwick, Compliance Officer, Division of West Coast Imports, 19701 Fairchild, Irvine, CA 92612. If you have any questions regarding this letter, you may contact Sundy Sedwick via email at sundy.sedwick@fda.hhs.gov. Please reference CMS # 553016 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