- Delivery Method:
- United Parcel Service
- Food & Beverages
Recipient NameMr. Khachik Doloukhanian
- K & K Distribution, Inc.
- Issuing Office:
- Division of West Coast Imports
April 15, 2021
Re: CMS # 612767
Dear Mr. Doloukhanian:
On December 3, 2020, the Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection of FSVP records that your firm was asked to submit to FDA. We also conducted an inspection on February 27, 2019. These inspections were conducted to determine your 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 will 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 your saffron imported from (b)(4); chick pea candies imported from (b)(4); and frozen broad bean (fava bean) imported from (b)(4). Your firm did not have FSVPs for these products. 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 FSVP inspection on February 27, 2019, and the follow-up inspection on December 3, 2020, our investigator provided you in each instance with a Form FDA 483a FSVP Observations.
We acknowledge receipt of your emailed responses on December 3, 2020, December 8, 2020, March 29, 2021, and April 9, 2021, which included attachments related to your broad bean (fava bean) product. Your December 3, 2020 email stated that you had “reached out to our manufacturing company in (b)(4) regarding the Fava Beans.” Your December 8, 2020 email provided attachments in a compressed file. After we requested individual files in March 2021, in your response on March 29, 2021, you provided FDA with copies of documents including a HACCP plan not translated to English, a pesticide analysis from your foreign supplier, a process flow diagram for frozen broad beans not translated to English, and copies of third-party audit certificates for your foreign supplier (b)(4) including a HACCP System Certificate, Food Safety Management System Certificate (ISO 22000:2005), and Global Standard for Food Safety BRC Certificate. On April 9, 2021, you provided English translations of the process flow diagram, hazard analysis, and HACCP plan for the frozen broad beans. In general, these documents could be used as part of your FSVP, but you did not provide your review of these documents. Our evaluation of these documents is discussed below.
Your significant violations of the FSVP regulations 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). Specifically, your firm did not develop an FSVP for each of the following foods: saffron imported from (b)(4) and chick pea candies imported from (b)(4).
2. For frozen broad beans from your foreign supplier, (b)(4), although you provided a HACCP plan and other documents from your foreign supplier, 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. As far as you rely on this hazard analysis 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 by 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). You did not provide documentation of your evaluation of your foreign supplier’s performance. 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 that they assessed compliance with FDA food safety regulations, as required by 1.506(e). You must also promptly review and assess the third-party audit, 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. Failure to adequately address this matter may result in 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 saffron imported from (b)(4); chick pea candies imported (b)(4); and frozen broad bean (fava bean) imported from (b)(4). We may place these foods from the identified foreign suppliers on detention without physical examination (DWPE) when your firm imports these 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.
In addition, we also have the following comment:
We note that you did not develop, maintain, and follow an FSVP for the products covered during your previous inspection in 2019: Anjoman Ceylon tea and Anjoman Earl Grey tea from (b)(4); and Indian 1121 sella rice from (b)(4). We acknowledge you reported you had not imported these products since 2018. However, if you should begin importing these products again, they must also be covered by an FSVP.
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 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). Please provide an English translation of any records that you provide in a language other than English in order to facilitate our review. 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 U.S Food and Drug Administration, Attention: David Serrano, Compliance Officer, Division of West Coast Imports, One World Trade Center, Suite 300, Long Beach, CA 90831. If you have any questions regarding this letter, you may contact Mr. Serrano via email at: firstname.lastname@example.org. Please reference CMS # 612767 on any documents or records you provide to us and/or within the subject line of any email correspondence you send to us in response to this letter.
Lawton W. Lum
Acting Program Division Director
Division of West Coast Imports