- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Food & Beverages
Recipient NameYounes Sayar
- Sayar Food Market, Inc.
3 Everett Street, Unit 3E
Revere, MA 02151
- Issuing Office:
- Division of Northeast Imports
July 13, 2021
Re: CMS # 614317
Dear Mr. Younes Sayar:
From February 16 through March 8, 2021, the Food and Drug Administration (FDA) conducted a remote Foreign Supplier Verification Program (FSVP) inspection of Sayar Food Market, Inc., located at 3 Everett St., Unit 3E, Revere, MA 02151.We also conducted an inspection on February 7, 2019. 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 any of the food products that you import, including (b)(4) imported from (b)(4), located in (b)(4); (b)(4) imported from (b)(4), located in (b)(4) and (b)(4) imported from (b)(4), located in (b)(4). You did not have FSVPs for these products or for any other food product 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 initial FSVP inspection on February 7, 2019 and the follow-up inspection on March 8, 2021, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations.
We have not received your response to either Form FDA 483a.
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 the following foods:
- (b)(4) imported from (b)(4)
- (b)(4) imported from (b)(4)
- (b)(4) imported from (b)(4)
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 provides 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)).
In addition to the above violations, we also have the following comments:
Your store manager reported that you do not directly import food products from multiple individual foreign firms, but instead from (b)(4), located in (b)(4). Your store manager also stated her understanding that your firm did not need to comply with the FSVP regulation because the products were imported from (b)(4), a country FDA has recognized as having an equivalent food safety system to that of the United States. The FSVP regulation defines a foreign supplier, in part, as the establishment that manufactures/processes the food that is exported to the United States without further manufacturing/processing by another establishment, except for further manufacturing/processing that consists solely of the addition of labeling or any similar activity of a de minimis nature (21 CFR 1.500). (b)(4), located in (b)(4), does not appear to meet the definition of a foreign supplier. Furthermore, if you did import certain food from a foreign supplier in, and under the regulatory oversight of, a country with an officially recognized or equivalent food safety system, you would still need to have an FSVP for those foods, but you could choose to follow the modified requirements applicable to such food in 21 CFR 1.513, including that before importing the food, you must determine and document whether the foreign supplier of the food is in good compliance standing with the food safety authority of the country in which the foreign supplier is located, as required in accordance with 21 CFR 1.513(b)(2).
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 these 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: Slater Bartlett, FDA Compliance Officer; Division of Northeast Imports: ORAOEIONEIMPORTSWLResponses@fda.hhs.gov. Please also cc (carbon copy) firstname.lastname@example.org. If you have any questions regarding this letter, you may contact Compliance Officer Bartlett via email at email@example.com. Please reference CMS # 614317 on any documents or records you provide to us and/or within the subject line of any email correspondence you send to us.
Program Division Director
Division of Northeast Imports
Younes Sayar, Owner
Sayar Distributors, Inc (Sayar Market, Inc.)
250 Industrial Drive
Halifax, MA 02338