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  5. Kradjian Importing Company, Inc. - 605815 - 05/04/2020
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WARNING LETTER

Kradjian Importing Company, Inc. MARCS-CMS 605815 —


Delivery Method:
United Parcel Service
Product:
Food & Beverages

Recipient:
Recipient Name
Raffi Kradjian
Recipient Title
CEO/President
Kradjian Importing Company, Inc.

5018 San Fernando Road
Glendale, CA 91204-1114
United States

Issuing Office:
Division of West Coast Imports

United States


WARNING LETTER

May 4, 2020

Re: CMS # 605815

Dear Mr. Kradjian:

On January 30, 2020, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection at Kradjian Importing Company Inc., 5018 San Fernando Road, Glendale, CA 91204. This inspection was 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 Foreign Supplier Verification Program (FSVP) implementing 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 inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for your tahina imported from your three foreign suppliers: (b)(4). You are also not in compliance with the requirements of 21 CFR part 1 subpart L for your canned chick peas/garbanzo beans imported from your foreign supplier (b)(4). You did not have FSVPs for the tahina you import from your (b)(4) foreign supplier, nor did you have an FSVP for the chick peas/garbanzo beans imported form your foreign supplier (b)(4). Additionally, the HACCP plans you presented as FSVPs to our investigator for your tahina products from your foreign suppliers (b)(4) contained several deficiencies. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.

At the conclusion of the FSVP inspection, our investigator provided you with Form FDA 483a, FSVP Observations. We have not received your response to the Form FDA 483a.

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 1.502(a) for tahina imported from foreign supplier (b)(4) or for canned chick peas/garbanzo beans imported from foreign supplier (b)(4). Specifically, your firm did not develop an FSVP for either product. In addition, for the canned chick peas/garbanzo beans, you did not verify and document that the food was produced in accordance with 21 CFR part 113 (regarding thermally processed low-acid foods packaged in hermetically sealed containers), as required by 21 CFR 1.502(b)(1).

2. For the tahina from your foreign suppliers, (b)(4), you did not meet your requirements to conduct a hazard analysis in accordance with 21 CFR 1.504 because you did not evaluate your foreign supplier’s performance in accordance with 21 CFR 1.505, nor did you perform foreign supplier verification activities in accordance with 21 CFR 1.506. During our inspection you provided FDA with copies of documents including a hazard analysis for tahina that was conducted by your foreign suppliers, (b)(4). As far as you rely on these hazard analyses to meet your obligations under the FSVP regulation, you did not provide FDA with any evidence that you documented your review and assessment of your foreign supplier’s hazard analysis as required per 21 CFR 1.504(d). You may meet your requirement to conduct a hazard analysis, as required under 21 CFR 1.504(a), by reviewing and assessing your supplier’s hazard analysis and documenting your review and assessment of that hazard analysis (21 CFR 1.504(d)). The FSVP regulation also generally requires that you evaluate your foreign supplier’s performance (21 CFR 1.505) and conduct foreign supplier verification activities (21 CFR 1.506), among other requirements. You failed to meet these requirements.

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 correct the above violations. If you do not promptly correct 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 tahina imported from your foreign suppliers (b)(4); and chick peas/garbanzo beans imported from your foreign supplier (b)(4). We may place these 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.

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 revised 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 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: Juliane Jung-Lau, 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 Ms. Jung-Lau via email at Juliane.Jung-Lau@fda.hhs.gov. Please reference CMS # 605815 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/

Dan R. Solis
Program Division Director
Division of West Coast Imports

 
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