FDA WARNING_LETTER - Eli’s Manhattan Warehouse, Inc. - September 07, 2021

On August 23 through September 7, 2021, the FDA conducted a remote Foreign Supplier Verification Program (FSVP) inspection of Eli’s Manhattan Warehouse, Inc., following a previous inspection on December 12, 2018. The inspection aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR part 1 subpart L, which mandate risk-based activities for importers to verify that imported food meets U.S. food safety standards.

The inspection revealed significant violations, specifically that Eli’s Manhattan Warehouse, Inc. did not develop, maintain, and follow an FSVP for any imported foods, as required by 21 CFR 1.502(a). This non-compliance was documented on a Form FDA 483a.

The company's email responses from September 24 and 27, 2021, stating they were obtaining documentation and seeking a consultant, were deemed inadequate. Submitted documents, including a hazard analysis and supply chain preventive controls in a foreign language, and a training certificate, lacked explanation on their applicability to the FSVP program.

Failure to address these violations may lead to further action, including refusal of admission for imported food products under section 801(a)(3) of the FD&C Act and placement on detention without physical examination (DWPE) under Import Alert #99-41.