- Delivery Method:
- Via Express Delivery
- Food & Beverages
Recipient NameMr. Khalil Saad
- Saad Trading Inc.
16322 W Warren Ave
Detroit, MI 48228-3703
- Issuing Office:
- Division of Northern Border Imports
Date: January 11, 2022
Re: CMS # 614485
Dear Mr. Khalil Saad:
From August 18 to September 21, 2021, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection of Saad Trading Inc. located at 14311 W. Warren Ave., Dearborn MI 48126-1458. We also conducted an inspection on March 4, 17, 24 and 30, 2021. 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.
Our March 2021 inspection was initiated as a result of an FDA sample finding of Salmonella in a plain halva product imported from your foreign supplier, (b)(4). In response to the FDA sample finding, we acknowledge that you voluntarily destroyed all the plain halva product in this shipment. Further on March 4, 2021, this product and foreign manufacturer combination was placed on the Red List of Import Alert 99-19 “Detention Without Physical Examination of Food Products Due to the Presence of Salmonella.” At the conclusion of our inspection, an FDA-483a was issued and we acknowledge receipt of your response dated April 14, 2021 containing various food safety documents from your foreign suppliers.
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 following foods you import: plain halva from (b)(4), tahina from (b)(4), and dried okra from (b)(4). 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 a Form FDA 483a FSVP Observations. To date we have not received a response to the issued FDA 483a.
Your significant violations of the FSVP regulation are as follows:
1. You must promptly investigate to determine whether your FSVP is adequate and, when appropriate, modify your FSVP when you became aware 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 FD&C 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), as required by 21 CFR 1.508(b). Further, you must document any investigations, corrective actions, and changes to your FSVP that you undertake. Your firm failed to document any review and assessment of your foreign supplier’s food safety plan after a sample of plain halva product you imported from your approved foreign supplier, (b)(4) tested positive for Salmonella. In addition, you did not modify your FSVP or document any changes you made to your FSVP as appropriate, after you determined that your foreign supplier was not in compliance with the applicable food safety requirements as a result of the positive sample.
In your FDA Form 483a response dated April 18, 2021, you stated that you “contacted the supplier and notify them with this issue and ask them to re-evaluate the whole process specially the hazard process and what the correction steps will be taken to prevent any issue in the future. . ..” However, we were unable to verify this investigation or any corrective actions during our most recent follow-up inspection because you did not provide FDA with documentation of any action you have taken as a result of the positive sample, such as your documented review and assessment of a recent audit report that includes a review of your foreign supplier’s environmental monitoring program.
2. You must conduct a 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(a). Although you may meet this requirement by reviewing and assessing the hazard analysis conducted by another entity using a qualified individual, you must document your review and assessment of that hazard analysis, including documenting that the hazard analysis was conducted by a qualified individual (21 CFR 1.504(d)). During our inspection, you provided a hazard analysis from your foreign suppliers for the tahina from your foreign supplier (b)(4) and for the halva from your foreign supplier (b)(4). However, you did not provide documentation that you have reviewed and assessed your foreign supplier’s hazard analyses or that this review and assessment was conducted by a qualified individual.
3. You must approve your foreign suppliers on the basis of an evaluation of your foreign supplier’s performance and the risk posed by the food, in accordance with 21 CFR 1.505(a) for products you import. Moreover, your evaluation must consider applicable FDA food safety regulations and information relevant to the foreign supplier’s compliance with those regulations, as required by 21 CFR 1.505(a)(1)(iii)(B) and you must document this evaluation in accordance with 21 CFR 1.505(a)(2). You did not document any evaluation of the performance of your foreign suppliers, (b)(4); and (b)(4) or your consideration of these suppliers’ compliance with the applicable FDA food safety regulations.
4. You did not meet the requirements to perform foreign supplier verification activities in accordance with 21 CFR 1.506. Specifically, 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) for the tahini imported from (b)(4); the plain halva imported from (b)(4) and the okra imported from (b)(4).
This letter notifies you of our concerns and provides you with 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 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 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 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 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: Mark Kaspar, Compliance Officer, DNBI, USFDA, 550 W Jackson, 15th Floor Chicago IL 60661. If you have any questions regarding this letter, you may contact Mark Kaspar via email at email@example.com. Please reference CMS # 614485 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
Mr. Khalil Saad, President
Saad Trading, Inc.
14311 W. Warren Ave.
Dearborn, MI 48126-1458