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WARNING LETTER

JR & Son World Trading LLC MARCS-CMS 612215 —


Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Food & Beverages

Recipient:
Recipient Name
Michael Rego
Recipient Title
President
JR & Son World Trading LLC

33 Wood Ave S, Ste 600
Iselin, NJ 08830-2717
United States

Issuing Office:
Division of Northeast Imports

United States


WARNING LETTER


Date: February 3, 2021

Re: CMS # 612215

Dear Mr. Rego:

From October 14 to November 10, 2020, the Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection of JR & Son World Trading LLC located at 33 S. Wood Avenue, Suite 600, Iselin, NJ 08830. We also conducted an inspection on March 9, 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 of 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 our most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for your Guava Paste (rectangular) imported from (b)(4) located in (b)(4); Coconut Water with Pulp imported from (b)(4) located in (b)(4); and Frozen Yellow Pepper Dices imported from (b)(4) located (b)(4). Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.

At the conclusion of both the initial inspection on March 9, 2018, and the follow-up inspection on November 10, 2020, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations.

During the closeout meeting, you stated you did not have a full understanding of FSVP and you would be willing to take the course in order to comply with the FSVP requirements. As of the date of this letter, we have not received your response to either Form FDA 483a.

Your significant violations of the FSVP regulation are as follows:

1. 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 the inspection, you provided copies of your foreign supplier (b)(4) hazard analysis for Guava Paste, your foreign supplier (b)(4) hazard analysis for Yellow Pepper Dices, and your foreign supplier (b)(4) hazard analysis for Coconut Water and Milk Drink Group. However, for each of these products, you did not provide documentation that you have reviewed and assessed your foreign supplier’s hazard analysis as required by 21 CFR 1.504(d).

2. For a low-acid canned food, you did not verify and document that the food was produced according to the low-acid canned foods regulations as required by 21 CFR 1.502(b)(1). Specifically, for a low-acid canned food, you did not document that the food (Coconut Water with Pulp) was produced according to the low-acid canned food regulations. 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 Coconut Water with Pulp was produced in accordance with 21 CFR part 113, as required by 21 CFR 1.502(b)(1).

3. You did not approve your foreign suppliers on the basis of 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, for your foreign suppliers (b)(4) you did not evaluate your foreign supplier’s performance and the risk posed by the food in accordance with 21 CFR 1.505(a), approve your foreign supplier on the basis of this evaluation, and document your approval, as required by 21 CFR 1.505(b).

4. You did not establish and follow written procedures to ensure that you import foods only from foreign suppliers you have approved 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, and document your use of these procedures, as required by 21 CFR 1.506(a)(1).

5. You did not establish written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import as required by 21 CFR 1.506(b). Specifically, you did not establish written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to the Guava paste that you imported from (b)(4) and the Coconut Water with Pulp imported from (b)(4).

6. You did not meet the requirements to conduct and document (or obtain documentation of) one or more of the supplier verification activities listed in 21 CFR 1.506(e)(1)(i) through (iv) for each foreign supplier before importing the food and periodically thereafter, as required by 21 CFR 1.506(e)(1). Specifically, you did not conduct and document or obtain documentation of one or more supplier verification activities before importing the food (Guava Paste from (b)(4), Coconut Water with Pulp, or Yellow Peppers Dices from (b)(4)) into the United States.

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.

You should take prompt action to address the above violations. If you do not promptly address them, 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 Guava Paste (rectangular) imported from (b)(4), Coconut Water with Pulp imported from (b)(4), and Frozen Yellow Pepper Dices imported from (b)(4). 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 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.

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 address 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 address any remaining violations.

Please send your reply to Food and Drug Administration, Attention: Feryal Ahmad, Compliance Officer, Division of Northeast Imports: ORAOEIONEIMPORTSWLResponses@fda.hhs.gov. Please also cc (carbon copy) Feryal.Ahmad@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Ahmad via email at Feryal.Ahmad@fda.hhs.gov. Please reference CMS# 612215 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.

Sincerely,
/S/

Dawne Hines
Program Division Director
Division of Northeast Imports

 
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