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WARNING LETTER

DF Global, Inc. MARCS-CMS 633242 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Sang Ki Lee
Recipient Title
Branch President & CEO
DF Global, Inc.

6221 Randolph St
Commerce, CA 90040-3514
United States

SK.LEE@DAMTUH.COM
Issuing Office:
Division of West Coast Imports

United States

August 1, 2022

WARNING LETTER

Re: CMS # 633242

Dear Mr. Sang Ki Lee:

On March 30, 2022, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of DF Global, Inc., located at 6221 Randolph St, Commerce, CA 90040-3514. We also conducted an inspection on January 15, 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 are not in compliance with the requirements of 21 CFR part 1, subpart L for the following foods you import: Honey Hallabong Tea, Agave Ginger Lemon Tea, and Walnut Almond Adlay Tea imported from (b)(6) located in (b)(6). Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.

At the conclusion of the FSVP inspection, our investigator provided you with a Form FDA 483a, FSVP Observations.

We acknowledge receipt of your response dated April 12, 2022, which stated that you have had an FSVP for all of your imported foods since February 2020 but you did not know which documents to provide during the most recent inspection. Your response also included records associated with your FSVPs for Honey Hallabong Tea, Agave Ginger Lemon Tea, and Walnut Almond Adlay Tea imported from (b)(6) located in (b)(6), such as copies of procedures, a certificate of HACCP Applied Establishment for (b)(6) from the (b)(6), an audit report for (b)(6) from the (b)(6), and hazard analyses for Honey Hallabong Tea, Agave Ginger Lemon Tea, and Walnut Almond Adlay Tea imported from (b)(6). We address your response below.

Your significant violations of the FSVP regulation are as follows:

1. 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 hazard means any biological, chemical (including radiological), or physical agent that is reasonably likely to cause illness or injury (see 21 CFR 1.500). A hazard requiring a control means a known or reasonably foreseeable hazard for which a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would, based on the outcome of a hazard analysis (which includes an assessment of the probability that the hazard will occur in the absence of controls or measures and the severity of the illness or injury if the hazard were to occur), establish one or more controls or measures to significantly minimize or prevent the hazard in a food and components to manage those controls or measures (such as monitoring, corrections or corrective actions, verification, and records) as appropriate to the food, the facility, and the nature of the control or measure and its role in the facility’s food safety system (see 21 CFR 1.500). Specifically, in your hazard analysis for “Tea (powder type: Walnut Almonds, etc),” which we understand to be for your Walnut Almond Adlay Tea imported from (b)(6), located in (b)(6), you did not identify the chemical hazards of undeclared allergens or natural toxins, such as mycotoxins in peanuts and tree nuts (which includes walnuts and almonds). According to the product labels you provided during the most recent inspection, Walnut Almond Adlay Tea contains milk, soy, peanut, walnut, and almond, which are food allergens. Food allergens are reasonably likely to cause illness or injury when undeclared on the package label, such that a control is required to ensure proper labeling. Moreover, you should evaluate whether food allergen controls are required to prevent or significantly minimize allergen cross-contact in the Honey Hallabong Tea and Agave Ginger Lemon Tea products manufactured by the same foreign supplier. You should also evaluate whether mycotoxins in peanuts and tree nuts are a hazard requiring a control for Walnut Almond Adlay Tea. However, you did not provide any information that suggests that food allergens or mycotoxins were identified as hazards requiring a control.

2. You did not meet the requirements to perform foreign supplier verification activities in accordance with 21 CFR 1.506(e) for the products you import. For an onsite audit, 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)). For a food that is subject to one or more FDA food safety regulations, an onsite audit of the foreign supplier must consider such regulations and include a review of the supplier’s written food safety plan, if any, and its implementation, for the hazard being controlled (21 CFR 1.506(e)(1)(i)(B)). Your third-party onsite audit report of (b)(6), from the (b)(6), dated April 22 through 23, 2021, includes the audit procedures, the dates the audit was conducted, and the conclusions of the audit. The audit report notes multiple deficiencies by the foreign supplier, including failure to establish standards for cleaning and disinfection, insufficient periodic inspection and calibration of refrigerators and measuring instruments, insufficient identification of possible hazards, insufficient preventive measures of raw materials and hazardous factors, and lack of understanding of concepts and procedures for hazard analysis. However, the audit report does not describe, nor have you provided other documentation of, the corrective actions taken in response to these significant deficiencies. You also did not provide any documentation showing that the audit assessed compliance with FDA food safety regulations, reviewed the supplier’s written food safety plan, or was conducted by a qualified auditor.

Additionally, as indicated above, the third-party onsite audit report found several issues with your foreign supplier’s performance. Note that when you become aware of new information about factors related to a foreign supplier’s performance and the risk posed by a food (see 21 CFR 1.505(a)(1) for a list of factors), such as the foreign supplier’s procedures, processes, and practices related to the safety of the food, applicable FDA food safety regulations and information relevant to the foreign supplier’s compliance with those regulations, or the foreign supplier’s food safety history, you must promptly reevaluate the concerns associated with these factors and document your reevaluation (see 21 CFR 1.505(c)).

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.

(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.

(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 from the identified foreign supplier 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.

We also offer the following comment:

During the most recent close out inspection, you stated that your Sales Manager and other personnel in your firm have received FSVP training. In addition, in your response to the Form 483a, you included several records prepared by your consultant, (b)(6). However, you did not provide FDA with training records or certificates of FSVP course completion for the personnel in your firm or (b)(6). Note that a qualified individual must develop your FSVP and perform FSVP activities, and a qualified individual must have the education, training, or experience (or a combination thereof) necessary to perform their assigned activities, as required by 21 CFR 1.503(a). This includes any consultants you may have relied on to develop your FSVP or perform FSVP activities.

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, 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 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: Sandra K. Wangen Compliance Officer, Division of West Coast Imports, 949 Market St, Suite 602, Tacoma, WA 98402. If you have any questions regarding this letter, you may contact Sandra K. Wangen via email at sandra.wangen@fda.hhs.gov. Please reference CMS # 633242 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/

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

 
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