- Delivery Method:
- Via Express Delivery
- Food & Beverages
Recipient NameMohammad Maber Mattan
- Aroma Imports, Inc.
27209 W. Warren Street
Dearborn Heights, MI 48127-1804
- Issuing Office:
- Division of Northern Border Imports
December 23, 2021
Zachariah Zaid Mattan, President
Re: CMS # 617818
Dear Messrs. Mattan:
On August 5, 2021 through August 26, 2021, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Aroma Imports Inc. located at 27209 W. Warren Street, Dearborn Heights, MI. 48127-1804. We also conducted an inspection on December 18, 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 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 inspections, our investigator provided you with a Form FDA 483a, FSVP Observations. We have not received your response to the Form FDA 483a that was issued on August 26, 2021.
Your significant violations of the FSVP regulation are as follows:
1. If you are a very small importer, for each food you import, you must obtain written assurance, in accordance with 21 CFR 1.512(b)(3), before importing the food and at least every two 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. During our inspection you told the investigator that you were working on getting “letters of assurance” from your suppliers, but you did not have written assurances, as required by 21 CFR 1.512(b)(3), for most of the products you import including, Ajwa dates imported from (b)(4) located in the (b)(4) and tahina imported from (b)(4) located in (b)(4).
2. You did not document that you took appropriate corrective actions after you were notified about an adulteration issue with your foreign supplier of food you import, in accordance with 21 CFR 1.512(b)(4). Specifically, on January 5, 2021, you voluntarily destroyed a shipment of halawa you imported from (b)(4) on or about November 1, 2020 after FDA notified you that we analyzed a sample collected from that shipment, detected Salmonella, and determined the halawa was adulterated under section 402 of the FD&C Act. FDA placed (b)(4) on Import Alert # 99-19, "Detention Without Physical Examination Of Food Products Due To The Presence Of Salmonella" on December 18, 2020. This foreign supplier remains on Import Alert #99-19.
Although you voluntarily destroyed the halawa on the shipment mentioned above, you again imported halawa with pistachio from (b)(4) on or about June 27, 2021 without documenting what corrective actions were taken by you in response to the Salmonella contamination. During the inspection you told our investigator that you had been in contact with your foreign supplier regarding the Salmonella findings in their products. You stated that (b)(4) believed the source of the contamination was the sesame seed ingredient and that it had been taken care of by the firm. You also obtained a written assurance dated June 2, 2021. However, you did not document any corrective action as required by 21 CFR 1.512(b)(4).
The above violation(s) 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.
We also have the following comments:
First, regarding your status as a very small importer, during the inspection you stated you were subject to the modified requirements as your firm meets the definition of a very small importer. We note that, based on your sales volume, you may meet the definition of a “very small importer” under 21 CFR 1.500. We were able to verify your status as a very small importer during our previous inspection on December 18, 2020. However, during the current inspection you did not provide documentation that you meet the definition of a very small importer. If you are a very small importer and you choose to comply with the modified requirements in 21 CFR 1.512, you must document that you meet the definition of very small importer on an annual basis as required per 21 CFR 1.512(b)(1)(i). You may choose to document your eligibility with tax forms or other accounting documents. You may find information on documenting your eligibility as a very small importer and the other requirements under 21 CFR 1.512 in the “Draft Guidance for Industry Foreign Supplier Verification Programs for Imports of Food for Human and Animals at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-foreign-supplier-verification-programs-importers-food-humans-and-animals. If you no longer qualify as a very small importer, the standard FSVP requirements would apply.
Second, when obtaining written assurances from foreign suppliers, the Draft Guidance for Industry cited in the comment above explains that you should ask your foreign supplier to provide this assurance on company letterhead or in a manner that clearly identifies the supplier, the particular food addressed in the assurance, and the applicable FDA food safety requirements. For example, if you are a very small importer of cookies, your supplier might provide the following assurance: “I affirm that these cookies were manufactured in accordance with FDA’s requirements for hazard analysis and risk-based preventive controls for human food, 21 CFR part 117, and that the cookies are not adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act (the Act) and not misbranded regarding labeling for major food allergens under section 403(w) of the Act.” The assurance from your foreign supplier should be dated and include the printed name and signature of an authorizing official.
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 Stated 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 https://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 send your reply to Food and Drug Administration, Attention: Julie Scoma, Compliance Officer, Division of Northern Border Imports, at Julie.Scoma@fda.hhs.gov. If you have any questions regarding this letter, you may contact Julie Scoma via email at the provided address. Please reference CMS #617818 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.
Keith J. Jasukaitis
Program Division Director
Division of Northern Border Imports