WARNING LETTER
D.K. Grocery Inc. DBA Apna Bazaar Cash and Carry
MARCS-CMS 606824 —
May 14, 2020
Delivery Method:
VIA EMAIL AND UNITED PARCEL SERVICE
Product:
Food & Beverages
Recipient:
Recipient Name
Khadag Singh
Recipient Title
President
D.K. Grocery Inc. DBA Apna Bazaar Cash and Carry
1700 Oak Tree Road
Edison
,
NJ
08820-2854
United States
Issuing Office:
Division of Northeast Imports
United States
WARNING LETTER
CMS # 606824
May 14, 2020
Dear Mr. Khadag Singh:
On February 27, 2020, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) follow-up inspection of D.K. Grocery Inc. DBA Apna Bazaar Cash and Carry located at 1700 Oak Tree Road, Edison, NJ. We also conducted an initial inspection on August 9, 2018. 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 our most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for the food products you import including, but not limited to, Chick Peas, Moth Whole Polished (aka Moth beans), and Chana Dal, imported from your foreign supplier,
(b)(4)
, located in
(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 on August 29, 2018 and the follow-up inspection on February 27, 2020, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations. We have not received your response to either Form FDA 483a.
Your significant violations of the FSVP regulation are as follows:
Your firm 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 the products that you import, including Chick Peas, Moth Whole Polished (aka Moth beans), and Chana Dal imported from your foreign supplier
(b)(4)
, located in
(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.
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 the food products you import. We may place the foods you import 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: Slater Bartlett, FDA Compliance Officer; Division of Northeast Imports: ORAOEIONEIMPORTSWLResponses@fda.hhs.gov. Please also cc (carbon copy) slater.bartlett@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Bartlett via email at slater.bartlett@fda.hhs.gov. Please reference CMS # 606824 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/
Dawne Hines
Program Division Director
Division of Northeast Imports
Content current as of:
05/26/2020
Regulated Product(s)
Food & Beverages