- Delivery Method:
- Via Express Delivery
- Food & Beverages
Recipient NameMr. Ravinder Kapoor
- Aman Kapoor In
1125 Howard St.
Elk Grove Village, IL 60007-2209
- Issuing Office:
- Division of Northern Border Imports
Re: CMS# 612711
March 10, 2021
Dear Mr. Ravinder Kapoor:
From December 1-17, 2020, the Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection of FSVP records that you submitted to FDA electronically for your firm, Aman Kapoor, Inc, located at 1125 Howard Street, Elk Grove Village, IL 60007-2209. We also conducted an inspection on September 13, 2017. 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 were not in compliance with the requirements of 21 CFR part 1 subpart L for your Cornflakes Mixture and Cashew Mixture imported from (b)(4). located in (b)(4) and your Dried Vegetable Soup Mix imported from (b)(4), located in (b)(4). Your firm did not have FSVPs for these foods. 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 September 13, 2017 and the follow-up inspection on December 17, 2020, our investigator provided you in each instance with a Form FDA 483a FSVP Observations.
We acknowledge that during our inspection you provided emails dated December 16, 2020 and December 17, 2020 which included several attached documents from your foreign supplier (b)(4), and from otherwise unidentified foreign suppliers. These documents appear to include hazard analyses, hazard plans, process flows, and risk analyses. None of the documents provided appear to correspond to the products covered during this inspection, as indicated above. You did not provide an explanation or description of how these documents relate to your FSVP. As of this date, we have not received an FDA483 response from you. 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). Specifically, your firm did not develop an FSVP for each of the following foods:
o Cornflake Mixture imported from (b)(4)
o Cashew Mixture imported from (b)(4)
o Dried Vegetable Soup Mix imported from (b)(4)
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 the food products you import that appear to be in violation of section 805. We may place the foods you import 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.
In addition to the above violations, we also have the following comments:
You must 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). Although you may meet this requirement by reviewing and assessing the hazard analysis conducted by another entity using a qualified individual, you must document 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 our inspection, you provided FDA with a copies of your foreign supplier (b)(4) hazard analysis for multiple products, however no hazard analyses were submitted for the Cornflake Mixture or Cashew Mixture. You also did not provide any documentation for the Dried Vegetable Soup Mix from your foreign supplier (b)(4). To the extent you intend to use your foreign supplier (b)(4)'s hazard analyses for certain products as part of your FSVPs, you did not provide documentation that you have reviewed and assessed your foreign supplier's hazard analysis or that the hazard analysis was conducted by a qualified individual.
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 will 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 the foods you import 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: Mark Kaspar, Compliance Officer, DNBI, USFDA. 550 W Jackson, 15th Floor Chicago IL 60661. If you have any questions regarding this letter, you may contact Mark Kaspar via email at firstname.lastname@example.org. Please reference CMS# 612711 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.
Keith J. Jasukaitis
Program Division Director
Division of Northern Border Imports
cc: Mr. Ravinder Kapoor, President
1125 Howard St.
Elk Grove village IL 6007-2209