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WARNING LETTER

Dream Wholesale, Inc MARCS-CMS 665405 —


Delivery Method:
Via Express Delivery
Product:
Food & Beverages

Recipient:
Recipient Name
Mr. Faris Hermiz
Recipient Title
President
Dream Wholesale, Inc

6000 Rinke Ave.
Warren, MI 48091-5350
United States

Issuing Office:
Division of Northern Border Imports

United States

Secondary Issuing Offices

United States


Date: February 15, 2024

WARNING LETTER

Re: CMS # 665405

Dear Mr. Faris Hermiz:

On May 16, 2023 and August 2, 2023, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Dream Wholesale, Inc. located at 6000 Rinke Ave., Warren, MI 48091-5350. We also conducted inspections on April 23 through April 30, 2020; June 25 through July 8, 2021; and May 18 through June 3, 2022. 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 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 FSVP inspection, our investigator provided you with a Form FDA 483a FSVP Observations.

We acknowledge receipt of your responses dated August 3, 2023, and September 12, 2023. Your response stated that for the FSVP observations, you were working to provide adequate hazard analysis for your imported products and that your suppliers “have not been cooperative in providing hazard analysis, and safety forms.” We are unable to evaluate the adequacy of any corrective actions because you have not provided any supporting documentation demonstrating your planned or completed corrective actions. To date, no additional FSVP documents have been received by FDA.

Your significant violations of the FSVP regulation are as follows:

1. Your analysis of the known or reasonably known foreseeable hazards in each food you import as described below did not include the types of hazards pursuant to 21 CFR 1.504(b)(1). You must conduct a written 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. Your hazard analysis must identify known or reasonably foreseeable hazards for each type of food you import to determine whether there are any hazards requiring a control (21 CFR 1.504(a)). The analysis of the known or reasonably foreseeable hazards in each food must include biological hazards, chemical hazards and physical hazards (21 CFR 1.504(b)(1)). A hazard means any biological, chemical, or physical agent that is reasonably likely to cause illness or injury (21 CFR 1.500). Specifically, while you provided FDA with your hazard analyses for the food you import, the hazard analyses you provided for your (b)(4) soda water, cooked chickpeas, grape leaves, dried apricot paste and frozen spinach, each state “Biological,” “Chemical,” and “Physical” but do not describe elements that appear to be hazards. For example, your hazard analysis for cooked chickpea lists “B=Biological: shelf life, C=Chemical: preservatives, P=Physical: packed in cans” but does not list any specific hazards (e.g., specific microorganisms or pathogens). In order to adequately determine which hazards require a control, the hazard analysis should identify the specific relevant hazard (e.g., the relevant microorganisms or pathogens). You indicated you are waiting for the hazard analyses from your foreign suppliers. Therefore, we find your analysis of the known or reasonably foreseeable hazards in each food did not include the types of hazards pursuant to 21 CFR 1.504(b)(1).

You may find guidance on how to conduct a hazard analysis and how to identify control measures for common biological (specifically bacterial pathogens), chemical and physical hazards associated with many processed foods at FDA’s Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food provides. You should consider how this guidance relates to each of the foods you import.

2. You did not establish and follow written procedures to ensure that you import foods only from approved 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). Specifically, you have not established written procedures for approving foreign suppliers for any of your imported foods, including for green cardamom from (b)(4), (b)(4) soda water from (b)(4), cooked chickpeas from (b)(4), grape leaves from (b)(4), dried apricot paste from (b)(4) and frozen spinach from (b)(4). During the inspection you were unable to provide records of your evaluation of your foreign suppliers’ performance and the risk posed by the foods you import.

3. You did not meet the requirements to perform foreign supplier verification activities in accordance with 21 CFR 1.506 for the products you import. Specifically, you did not document your determination or performance of appropriate supplier verification activities for green cardamom from (b)(4), (b)(4) soda water from (b)(4), cooked chickpeas from (b)(4), grape leaves from (b)(4), dried apricot paste from (b)(4) and frozen spinach from (b)(4). In your 483 response, you have requested information from your foreign suppliers to complete a review of the verification activities, but you have not provided any documentation of this evaluation. Furthermore, you did not establish written procedures for ensuring that appropriate supplier verification activities are conducted in accordance with 21 CFR 1.506(b), and you did not document your determination of the appropriate supplier verification activity in accordance with 21 CFR 1.506(d). During the establishment inspection you were unable to provide the required documentation.

4. You did not promptly investigate to determine whether your FSVP is adequate and, when appropriate, modify your FSVP after you determined by means other than the verification activities conducted under 1.506 or a reevaluation conducted under 1.505(c) or (d), that a foreign supplier of food that you import does not produce 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 Federal Food, Drug, and Cosmetic Act, if either is applicable, and the implementing regulations, or produces food that is adulterated under section 402 or misbranded under section 403(w) (if applicable) of the Federal Food, Drug and Cosmetic Act, as required by 21 CFR 1.508(b). Specifically, you did not promptly investigate and document your investigation to determine whether your FSVP is adequate when FDA informed you that certain foods you import had been sampled by FDA and found results that supported that the foods were adulterated. For example, your dried apricot paste from (b)(4), was sampled and found to contain lead at levels such that the product was deemed adulterated and refused and your frozen spinach from (b)(4) was sampled and found to contain pesticides for which there are no tolerance in this food and the product was deemed adulterated and refused and your cooked chickpeas from (b)(4) were sampled and found to have an elevated pH range which is a process deviation and rendered the product adulterated. You must document any investigations, corrective actions, and changes to your FSVP that you undertake in accordance with 21 CFR 1.508(b).

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.

Please note that while you indicated that Listeria and Salmonella are hazards requiring a preventive control in green cardamom, based on the available information, it does not appear that your supplier has a control in place to control the hazards.

You should take prompt action to address the above violations. If you do not promptly address this matter, we may take further action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of the green cardamom imported from (b)(4); (b)(4) soda water imported from (b)(4); cooked chickpeas imported from (b)(4); grape leaves imported from (b)(4); dried apricot paste imported from (b)(4); and frozen spinach imported from (b)(4). We may place the foods from the identified foreign suppliers on detention without physical examination (DWPE) when you import the products. 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 address any violations. You should include in your response documentation and information that would assist us in evaluating your response, (e.g., documentation of changes you made, such as a copy of your revised FSVP, records to demonstrate implementation of your revised 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 addressing these violations within 15 days, you should explain the reason for your delay and state the time within which you will do so.

Please send your reply to Food and Drug Administration, Attention: Mark Kaspar, Compliance Officer, DNBI, USFDA, 550 W Jackson, 8th Floor, Chicago IL 60661. If you have any questions regarding this letter, you may contact Mark Kaspar via email at mark.kaspar@fda.hhs.gov. Please reference CMS #665405 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/

Keith J. Jasukaitis
Program Division Director
Division of Northern Border Imports

cc:

Mr. Faris Hermiz, President
Dream Wholesale, Inc
6000 Rinke Ave.
Warren, MI 48091-5350
dreamwholesaleinfo@gmail.com

 
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