WARNING LETTER
Kuzmir Imports Inc.
MARCS-CMS 633082 —
August 02, 2022
Delivery Method:
VIA EMAIL AND UNITED PARCEL SERVICE
Product:
Food & Beverages
Recipient:
Recipient Name
Yehuda Loeffler
Recipient Title
President
Kuzmir Imports Inc.
201 Route 59, Building A1
Hillburn
,
NY
10931
United States
Issuing Office:
Division of Northeast Imports
United States
WARNING LETTER
Re: CMS # 633082
Dear Mr. Loeffler:
From March 10 to 23, 2022, the U.S. Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Kuzmir Imports Inc., located at 210 Route 59, Building A1, Hillburn, New York 10931. We also conducted inspections on April 30 to May 6, 2020, and May 9, 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 the following foods you import: mini soup croutons onion garlic from your foreign supplier
(b)(4)
located in
(b)(4)
; nougat spread from your foreign supplier
(b)(4)
located in
(b)(4)
; and cashews from your foreign supplier
(b)(4)
located in
(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. We have not received your response to the Form FDA 483a issued on March 23, 2022.
Your significant violations of the FSVP regulation are as follows:
1. You did not 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). 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 and documenting 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 multiple documents related to your mini soup croutons onion garlic from foreign supplier
(b)(4)
located in
(b)(4)
, nougat spread from foreign supplier
(b)(4)
located in
(b)(4)
, and cashews from foreign supplier
(b)(4)
located in
(b)(4)
, including specification sheets and process flow charts provided by your foreign suppliers. You also provided a document described as a “HACCP study – caramelizing” for an unidentified product. To the extent the information in these documents may assist you in conducting a hazard analysis for the respective foods, you did not document that you conducted a hazard analysis to determine whether there are any hazards requiring a control in accordance with 21 CFR 1.504.
2. 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, for
(b)(4)
located in
(b)(4)
,
(b)(4)
located in
(b)(4)
, and
(b)(4)
located in
(b)(4)
, you did not evaluate your foreign supplier’s performance and risk posed by the food in accordance with 21 CFR 1.505(a) or approve your suppliers based on this evaluation and document your approval in accordance with 1.505(b). During the inspection you provided your one-page FSVP protocol document dated January 15, 2022, that stated that you obtain a sample of the product, review the product to ensure it is safe for consumption, review label information, and receive manufacturer “spec. sheet, flow chart, and letter of guarantee.” You did not provide any further details about the sample of the product, what you consider for determining that the product is safe for consumption, or what is included in the letters of guarantee. You also provided multiple certificates for your foreign suppliers, including but not limited to, an NSF Global Standard for Food Safety for
(b)(4)
, a Control Union Food Safety System Certification (FSSC) 22000 certification for
(b)(4)
, and an IQC FSSC 22000 certification for
(b)(4)
However, you did not document your review or otherwise describe how you used these documents to comply with FSVP requirements and you did not document your evaluation of the performance of your foreign suppliers or risks posed by the relevant foods as required by 21 CFR 1.505(a)(2). Further, you did not document your approval of your foreign suppliers as required per 21 CFR 1.505(b).
3. You did not meet the requirements to perform foreign supplier verification activities in accordance with 21 CFR 1.506 for the products you import. Specifically, you did not document your determination or performance of appropriate supplier verification activities for mini soup croutons onion garlic from foreign supplier
(b)(4)
located in
(b)(4)
; nougat spread from foreign supplier
(b)(4)
located in
(b)(4)
; and cashews from foreign supplier
(b)(4)
located in
(b)(4)
. Furthermore, 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). Your one-page FSVP protocol document dated January 15, 2022, states in part that you obtain a sample of the product and receive manufacturer “spec. sheet, flow chart, and letter of guarantee.” While you may determine that sampling and testing of the food, or review of the foreign supplier's relevant food safety records may be an appropriate verification activity, you did not retain documentation of such determination as required by 21 CFR 1.506(e)(1)(ii) and (iii) respectively. Additionally, while you provided several audit certificates, you did not provide any documentation that you reviewed and assessed the results. While you may rely on supplier verification activities conducted in accordance with 21 CFR 1.506(e)(1) by another entity, you must promptly review and assess the results of the verification activities conducted by another entity and document your review and assessment (21 CFR 1.506(e)(3)).
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 comply 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 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: Feryal Ahmad, Compliance Officer, Division of Northeast, 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# 633082 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.
Sincerely,
/S/
CDR Joseph Tomao
Acting Program Division Director
Division of Northeast Imports
Content current as of:
09/13/2022
Regulated Product(s)
Food & Beverages