JD's Market Inc. – FDA Warning Letter, May 21, 2021

On October 15, 2021, the FDA issued a Warning Letter to JD’s Market Inc. following remote Foreign Supplier Verification Program (FSVP) inspections on May 3 and May 17-21, 2021, and a previous inspection on March 1, 2019. The inspections 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 human and/or animal food meets U.S. food safety standards.

The FDA found significant violations, specifically that JD’s Market Inc. did not develop, maintain, and follow an FSVP for any imported foods, as required by 21 CFR 1.502(a). This non-compliance also violates section 805 of the FD&C Act. A Form FDA 483a, FSVP Observations, was issued on May 21, 2021, but no response was received.

Failure to address these violations may lead to further action, including refusal of admission for imported food under section 801(a)(3) of the FD&C Act and placement on detention without physical examination (DWPE) via Import Alert #99-41. Importing food without a compliant FSVP is also prohibited under section 301(zz