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  5. NAFTA Distributors Inc. - 658788 - 06/21/2023
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WARNING LETTER

NAFTA Distributors Inc. MARCS-CMS 658788 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Samuel Madikians
Recipient Title
Owner
NAFTA Distributors Inc.

5120 Santa Ana St
Ontario, CA 91761-8632
United States

Issuing Office:
Division of West Coast Imports

United States

June 21, 2023

WARNING LETTER

Re: CMS # 658788

Dear Mr. Madikians:

On February 7 through February 21, 2023, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of NAFTA Distributors Inc. located at 5120 Santa Ana St Ontario, CA 91761-8632. We also conducted an inspection on July 17 through July 19, 2018. 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 have 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-ruleforeignsupplier-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 a Form FDA 483a FSVP Observations. To date, we have not received your response to the Form FDA 483a issued on February 21, 2023.

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 part 1.502(a). Specifically, Specifically, you did not develop, maintain, and follow an FSVP for the following foods you import:

  • Lollipop and Candy Specialties, imported from (b)(4)
  • Candy, imported from (b)(4)
  • Blended vegetable oils, imported from (b)(4)
  • (b)(4) jam, jelly, preserves, marmalade, butter or candied, and candy, imported from (b)(4)
  • Cookies, caramel, and candy, imported from (b)(4)
  • (b)(4) and lollipop, imported from (b)(4)
  • Milk and cream, or candy bar or ieces, imported from (b)(4)
  • Gelatin, imported from (b)(4)
  • Candy specialties, chewing gum, imported from (b)(4)
  • Gelatin, imported from (b)(4)
  • (b)(4), lollipop, candy specialties, chewing gum, imported from (b)(4)
  • (b)(4), jam, jelly, preserves, marmalade, butter and candied, caramel candy bar, soft candy, lollipop, candy specialties, imported from (b)(4)
  • Candy specialties, imported from (b)(4)
  • Gelatin, imported from (b)(4)
  • Peanuts, candy bar, marshmallow candy, chocolate candy, imported from (b)(4)
  • Pepper sauce, imported from (b)(4)
  • Candy, imported from (b)(4)
  • Soda water, imported from (b)(4)
  • Salt, imported from (b)(4)

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 your requirement to determine whether there are any hazards requiring a control 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)). Specifically, during the inspection you provided your hazard analyses from your foreign suppliers for mega marshmallows from (b)(4), hot sauce from (b)(4). However, you did not provide documentation that you reviewed and assessed your foreign supplier’s hazard analysis as required by 21 CFR 1.504(d). Furthermore, you did not have a hazard analysis for any other food you import.

3. You did not approve your foreign suppliers based on an evaluation of the foreign supplier’s performance and the risk posed by the food, conducted in accordance with 21 CFR 1.505(a), and document your approval, as required by 21 CFR 1.505(b). Specifically, while you provided your established written procedures to ensure that you import foods only from foreign suppliers you have approved based on the evaluation conducted under § 1.505, you did not document your use of these procedures, as required by 21 CFR 1.506(a)(1) for any of your imported foods. During the inspection, you provided a document titled, “Nafta Distributors Foreign Supplier Verification Program (FSVP)” and copies of food safety plans from your foreign suppliers, (b)(4). However, you did not document your review of these food safety plans or any other information regarding your evaluation of your foreign suppliers’ performance and the risk posed by the food, as required by 21 CFR 1.505(a) or your approval of these suppliers, as required by 1.505(b).

4. You did not meet the requirement to perform foreign supplier verification activities as required by 21 CFR 1.506. Specifically, you did not document your determination of the appropriate supplier verification activity or activities, or the frequency with which the activity or activities must be conducted, as required by 21 CFR 1.506(d). During the inspection, you told our investigator that you conduct site visits and review third party audits for all your foreign suppliers, but you do not document your site visits or your review of the audits. You did not document or obtain documentation of supplier verification activities, as required under 21 CFR 1.506(e)(1). With respect to the requirements of 21 CFR 1.506(e), regarding the performance of foreign supplier verification activities, while you may rely on third-party food safety audits as part of your foreign supplier verification activities, you must ensure the audit is performed by a qualified auditor and considers applicable FDA food safety regulations (or, when applicable, an onsite audit may consider relevant laws and regulations of a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States). You must also promptly review and assess any third-party audit that constitutes a verification activity, as well as document your review and assessment, among other requirements (21 CFR 1.506(e)).

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. 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: Courtney Warren, Compliance Officer, Division of West Coast Imports, 1201 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding this letter, you may contact Courtney Warren via email at Courtney.Warren@fda.hhs.gov . Please reference CMS 658788 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.

Sincerely,
/S/

Dr. Kathleen Turner
Program Division Director
Division of West Coast Imports

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