- Delivery Method:
- Via Express Delivery
- Food & Beverages
Recipient NameKamil Hindy
- Hindy Import Inc.
1243 Vernon Way
El Cajon, CA 92020
- Issuing Office:
- Division of Southwest Imports
January 9, 2020
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
o 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
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.
Director Division of Southwest Imports