- Delivery Method:
- VIA EMAIL AND UNITED PARCEL SERVICE
- Food & Beverages
Recipient NameEli Zabar
- Eli’s Manhattan Warehouse, Inc.
1064 Madison Avenue
New York, NY 10028
- Issuing Office:
- Division of Northeast Imports
December 14, 2021
Re: CMS 618952
Dear Mr. Eli Zabar:
On August 23 through September 7, 2021, the Food and Drug Administration (FDA) conducted a remote Foreign Supplier Verification Program (FSVP) inspection of Eli’s Manhattan Warehouse, Inc. located at 1064 Madison Avenue New York, NY 10028. We also conducted an inspection on December 12, 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 the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for the foods you import. Because of these significant violations, you are not in compliance with Section 805 of the FD&C Act.
At the conclusion of the inspection, our investigator provided you with a Form FDA 483a, FSVP Observations. We acknowledge receipt of your email responses, dated September 24, 2021 and September 27, 2021, and we address your response below.
You stated you are in the process of obtaining documentation from your foreign suppliers and that you are seeking a consultant to review your FSVP process. You provided a hazard analysis in a language other than English, supply chain preventive controls in a language other than English, an FSPCA Preventive Controls for Human Food training certificate for an unidentified individual, and an email correspondence with a customs broker in which you request a recommendation for an FSVP consultant. We are unable to evaluate the adequacy of this response because while it appears that some of these documents may have been provided by one of your foreign suppliers, you did not explain how they would apply to your FSVP program.
Your significant violation of the FSVP regulation is as follows:
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, you did not develop, maintain, and follow an FSVP for any of the foods you import, including each the following food products:
- Blueberry, strawberry, cherry jams from (b)(4) located in (b)(4)
- Olive oil from (b)(4) located in (b)(4)
- Honey from (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.
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. We may place the foods you import on detention without physical examination (DWPE) when you import the foods. 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 any 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. 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) firstname.lastname@example.org. If you have any questions regarding this letter, you may contact Compliance Officer Bartlett via email at email@example.com. Please reference CMS # 618952 on any documents or records you provide to us and/or within the subject line of any email correspondence you send to us.
CAPT Nazmul Hassan
Program Division Director
Division of Northeast Imports
Janine Howe, CFO
Eli’s Manhattan Warehouse, Inc.
1064 Madison Ave
New York, NY 10028