- Delivery Method:
- Via Express Delivery
- Food & Beverages
Recipient NameAbdulFattah Alnedhami
- Green City Distribution
13250 Rotunda Drive
Dearborn, MI 48120-1230
- Issuing Office:
- Division of Northern Border Imports
June 30, 2021
CMS # 614346
Dear Mr. Alnedhami:
From March 25 - 29, 2021, the Food and Drug Administration (FDA) conducted a remote Foreign Supplier Verification Program (FSVP) inspection of Green City Distribution located at 13250 Rotunda Drive, Dearborn, MI. We also conducted inspections on November 8, 2018 and June 5, 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 FSVP implementing 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 any of the foods you import from your foreign suppliers, including your broad beans imported from your foreign supplier (b)(4), broad beans imported from your foreign supplier (b)(4), kidney beans imported from your foreign supplier (b)(4), and coconut fudge imported from your foreign supplier (b)(4). You did not have FSVPs for these products. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.
At the conclusion of the FSVP inspections on November 8, 2018, June 5, 2020 and the follow-up inspection on March 25, 2021, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations.
We acknowledge receipt of your email response dated April 7, 2021 in which you stated that you “are planing [sic] to get all the FSVP plan within 7 months from now.” We note that our latest FSVP inspection follows two previous FSVP inspections of your firm within the past three years, each of which demonstrated your firm’s failure to develop, maintain, and follow FSVPs.
Your significant violations of the FSVP regulation 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 any of the foods you import, including the following foods:
• broad beans manufactured by (b)(4).
• broad beans manufactured by (b)(4)
• kidney beans manufactured by (b)(4)
• coconut fudge manufactured by (b)(4)
2. For thermally processed low‐acid foods packaged in hermetically sealed containers (low-acid canned foods), with respect to those microbiological hazards that are controlled by following 21 CFR part 113, you must verify and document that the food was produced in accordance with 21 CFR part 113, as required by 21 CFR 1.502(b)(1). You did not verify and document that your products – canned broad beans and kidney beans – low-acid canned foods, were produced in accordance with 21 CFR part 113 , as required by 21 CFR 1.502(b)(1).
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 provide you an opportunity to address them. Failure to adequately address this matter may result in 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 products you import for which you appear to be in violation of section 805. We may place the foods you import 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 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 days, you should explain the reason for your delay and state when you will correct any remaining violations.
Please email your reply to Food and Drug Administration, Attention: Julie Scoma, Compliance Officer, Division of Northern Border Imports, at Julie.Scoma@fda.hhs.gov. Please reference CMS # 614346 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.
Acting Program Division Director
Division of Northern Border Imports