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WARNING LETTER

Grow Gold Land, Inc. MARCS-CMS 709308 —

Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Food & Beverages
Recipient:
Recipient Name
Yongyi (NMI) Zhang
Recipient Title
CEO
Grow Gold Land, Inc.

10423 Valley Blvd Ste L
El Monte, CA 91731
United States

Issuing Office:
Office of Inspections and Investigations

United States

May 27, 2025

WARNING LETTER

Re: CMS 709308

Dear Mr. Zhang:

On April 14, 2025, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Grow Gold Land, Inc., located at 10423 Valley Blvd Ste L El Monte, CA 91731. This inspection was 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 FSVP regulation in 21 CFR part 1, subpart L.

The FSVP regulation requires that importers perform certain risk-based activities to verify the 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 inspection, we found that you are not in compliance with the requirements of 21 CFR part 1, subpart L for the foods 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 have not received your response to the Form FDA 483a issued on April 14, 2025.

Your significant violations of the FSVP regulation are as follows:

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 any of the foods you import, including each of the following foods:

  • Dried Lily Flower, imported from (b)(4), located in (b)(4)
  • Dried Tea Tree Mushroom, imported from (b)(4), located in (b)(4)
  • Dried Mushroom Shiitake, imported from (b)(4), located in (b)(4)

In your response on May 5, 2025 – you provided the following document: Supplier Food Safety Compliance Assurance Letter for (b)(4), your foreign supplier for dried mushroom. You asked whether the written assurance was adequate for submission. However, it is not clear how the document would apply to your FSVP program, and you did not explain how they would apply to your FSVP program.

During our inspection, you indicated you choose to comply with the requirements for very small importers and may meet the definition of a “very small importer” under 21 CFR 1.500. If you choose to comply with the modified requirements in 21 CFR 1.512, you must document that you meet the definition of a very small importer as required by 21 CFR 1.512(b)(1)(i). You are also still 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. In addition, for each food you import, you must obtain written assurance, before importing the food and at least every 2 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 (21 CFR 1.512(b)(3)(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.

In addition, FDA has determined that your facility located at 10423 Valley Blvd Ste L El Monte, CA 91731, (b)(3)(A).

As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.

We request that the owner, operator, or agent in charge of this facility, or an individual authorized by this facility’s owner, operator, or agent in charge, (b)(3)(A).

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 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 the Food and Drug Administration, Attention: Timothy S. Williamson, Compliance Officer, Division of West Coast Imports, One World Trade Center, Suite 300, Long Beach, CA 90831, with a copy via electronic mail to WCID@fda.hhs.gov. If you have any questions regarding this letter, you may contact the Compliance Officer via email at Timothy.Williamson@fda.hhs.gov.

Please reference CMS # 709308 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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