FDA Issues Warning Letters To Two Importers for No FSVP

FDA issued Warning Letters to two importers for not having Foreign Supplier Verification Programs in place for their international suppliers.

• Banjaras Inc of Texas did not have a FSVP in place for suppliers of coriander and garlic, Rasam powders, Kesar mango pulp and Suji rusk.
• Hindy Import Inc. of Cajon, CA did not have a FSVP for suppliers of red lentils, bulgur coarse with vermicelli noodles, and vermicelli noodles, and white quinoa.

Whether a company is directly importing product or if they are using importers to bring in product, someone must be responsible for evaluating the safety of that product. While manufacturers who directly import food or ingredients can do that as part of their Preventive Controls plan, if they are using an importer, then it is critical to understand who has a program in place to evaluate and ensure the safety of that product. For food manufacturers, they often assume the broker is covering the regulatory requirements, but without delineating that on a contractual basis, one does not know for certain.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/banjaras-inc-589115-09252019
FDA WARNING LETTER
Banjaras Inc
MARCS-CMS 589115 — September 25, 2019

Recipient:
Ms. Sunit Kaur
President
Banjaras Inc
2707 Gallion Dr.
Sugar Land, TX 77479-1979
United States

Issuing Office:Division of Southwest Imports
United States

September 24, 2019
WARNING LETTER
Re: CMS # 589115

Dear Ms. Kaur:

On August 21, 2017, the Food and Drug Administration conducted an Foreign Supplier Verification Program (FSVP) inspection at 2702 Galion Dr., Sugar Land, TX 77479-1979. We also conducted an inspection on July 10, 2019. 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 the most recent inspection, we found that you were not in compliance with the requirements of 21 CFR part 1 subpart L for your coriander and garlic and Rasam powders from foreign supplier (b)(4)., your Kesar mango pulp from foreign supplier (b)(4), and your Suji rusk from foreign supplier (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 the FSVP inspection, our investigator provided you with Form FDA 483a, FSVP Observations.

However, we have not received your response to the Form FDA 483a.

Your significant violations are described below:
You did not develop an FSVP as required by section 805 of the FD&C Act and 21 CFR part 1 subpart L. Specifically, your firm did not develop an FSVP for each of the following foods:

•Coriander with garlic manufactured by (b)(4) (e.g., entry #KM6- 3516695-2 line 21/3)
•Rasam powder manufactured by (b)(4) (e.g., entry # KM6- 3516695-2 line 101/1)
•Kesar mango pulp manufactured by (b)(4) (e.g., entry #KM6-3523053- 5 line 11/1)
•Suji rusk manufactured by (b)(4) (e.g., entry #KM6-3523668-0 Line 91/2)

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 implementing FSVP regulation in 21 CFR part 1 subpart L.

You 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 Coriander and garlic and Rasam powder manufactured by (b)(4); Kesar mango pulp manufactured by (b)(4); Suji rusk manufactured by (b)(4). We may place the foods on detention without physical examination (DWPE) when you import the products. You can find DWPE information relating to FSVP on 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 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 believe that your products 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 Food and Drug Administration, Attention: Rosa Linda Santos, Compliance Officer, Division of Southwest Imports, 4040 N. Central Expressway, Suite 300, Dallas, TX 75204.

If you have any questions regarding this letter, you may contact CO Santos via email at rosa.santos@fda.hhs.gov. Please reference CMS #589115 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/
Todd Cato
District Director
Division of Southwest Imports

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hindy-import-inc-591679-01092020
FDA WARNING LETTER

Hindy Import Inc.
MARCS-CMS 591679 — January 09, 2020

Recipient:
Kamil Hindy
Owner
Hindy Import Inc.
1243 Vernon Way
El Cajon, CA 92020
United States

Issuing Office:Division of Southwest Imports
United States

January 9, 2020

WARNING LETTER
Re: CMS # 591679

Dear Mr. Hindy:

On May 7, 2019, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection at 1246 Vernon Way, El Cajon CA. We also conducted an inspection on December 10, 2018. 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 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 our May 7, 2019 inspection, we found that you are not in compliance with the requirements of 21 CFR Part 1 subpart L for your dry food products like red lentils, bulgur coarse with vermicelli noodles, and vermicelli noodles, imported from Bashan Tarimsal Urun Paz San Ve Dis Tic A.S. located in Mersin, Turkey, and white quinoa imported from (b)(4). You 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 and our follow-up inspection on May 7, 2019, our investigator provided you with Form FDA 483a, FSVP observations.

We acknowledge that during a follow-up regulatory meeting on June 13, 2019 you stated that you would look for a consultant to help you with FSVP compliance. Subsequently, on September 9, 2019, you sent an email containing an estimate for a supplier compliance monitoring service. We cannot evaluate this email because you did not provide supporting documentation that you are now in compliance with FSVP.

Your significant deviation is described below:

•You did not develop an FSVP as required by section 805 of the FD&C Act and 21 CFR part 1 subpart L for each of the following food:
o bulgur coarse with vermicelli and vermicelli noodle food products imported from Bashan Tarimsal Urun Paz San Ve Dis Tic A.S. located in Mersin, Turkey
 white quinoa imported from (b)(4).

Our finding during the May 7, 2019 inspection was consistent with our finding during the previous inspection of your firm. During a December 10, 2018 inspection, we also found that your firm was not in compliance with section 805 of the FD&C Act because your firm did not develop an FSVP for the foods covered by that inspection.

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 lentils, bulgur coarse with vermicelli, and vermicelli noodles imported from Bashan Tarimsal Urun Paz San Ve Dis Tic A.S., Mersin Turkey; and white quinoa 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 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 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 Food and Drug Administration, Attention: Barbara Rincon

Alexander Lopez
Director, Compliance Branch
U.S. Food and Drug Administration
4040 North Central Expressway, Suite 300
Dallas, TX 7520

If you have any questions regarding this letter prior to your written response, you may contact Barbara Rincon, Compliance Officer at telephone number (619) 941-3691 or via email at Barbara.Rincon@fda.hhs.gov. Please reference CMS #591679 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/
Todd Cato
Director Division of Southwest Imports