WARNING LETTER
Anglo Freight USA Inc.
MARCS-CMS 688299 —
August 05, 2024
Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Nomum Bukhochir
Recipient Title
Owner
Anglo Freight USA Inc.
417 Lively Blvd
Elk Grove Village
,
IL
60007-2011
United States
anglofreightchicago@gmail.com
Issuing Office:
Division of Northern Border Imports
United States
August 5, 2024
WARNING LETTER
Re: CMS # 688299
Dear Mr. Nomum Bukhochir:
From 05/20/2024 through 07/01/2024, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Anglo Freight USA Inc., 417 Lively Blvd. Elk Grove Village, IL 60007-2011. There were also previous FSVP inspections conducted from 07/19/2022 through 08/12/2022, and 06/16/2023 through 07/14/2023. 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-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 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 Form FDA 483a FSVP Observations. We have received your response to the Form FDA 483a issued on 07/01/2024. The response did not contain any FSVP documentation and was found to be inadequate.
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:
FLOUR from foreign supplier
(b)(4)
KUMIS from foreign supplier
(b)(4)
SEABUCKTHORN JUICE from foreign supplier
(b)(4)
TEAS from foreign supplier Anglo Freight, Mongolia
During our inspection, you indicated you chose to comply with the requirements for very small importers and 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 471 Lively Blvd, Elk Grove Village, IL 60007-2011is subject to the food facility registration requirement in section 415 of the FD&C Act (21 U.S.C. 350d) and our implementing regulations at 21 CFR part 1, subpart H. During the most recent inspection, you were advised of this requirement. Our records indicate that, to date, your facility has not been registered with FDA. Failure to register a facility as required is a prohibited act under section 301(dd) of the FD&C Act (21 U.S.C. 331(dd)).
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, register the facility with FDA within 30 working days of the date of this letter. Food facility registration guidance is available online at https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/registration-food-facilities-and-other-submissions. Registration may be accomplished online at http://www.access.fda.gov. You must submit your registration or registration renewal to FDA electronically, unless FDA has granted you a waiver under 21 CFR 1.245 (21 CFR 1.231(a)(4)).
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 Food and Drug Administration, Attention: Joseph DiNardo, Compliance Officer, Division of Northern Border Imports. If you have any questions regarding this letter, you may contact Compliance Officer Joseph DiNardo via email at joseph.dinardo@fda.hhs.gov. Please reference CMS #688299 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.
Sincerely,
/S/
Keith J. Jasukaitis
Program Division Director
Division of Northern Border Imports
Content current as of:
08/27/2024
Regulated Product(s)
Food & Beverages