FDA WARNING_LETTER - E&H Distributors Llc - August 04, 2020

On November 4, 2020, the FDA issued a Warning Letter to E & H Distributors LLC, following a remote follow-up Foreign Supplier Verification Program (FSVP) inspection from May 5 to August 4, 2020. This inspection, along with an initial inspection on September 12, 2017, aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L.

The FDA found that E & H Distributors LLC was not in compliance with FSVP requirements for imported "(b)(4) soft tamarind flavored candy" from foreign supplier "(b)(4)" and "(b)(4) candy" from foreign supplier "(b)(4)". Specifically, the firm failed to develop, maintain, and follow an FSVP for these products, as required by 21 CFR 1.502(a). A document submitted by the firm, titled "Determining the FSVP Importer," was deemed insufficient as it was not specific to the firm, its products, or foreign suppliers, and did not provide adequate assurances of compliance with U.S. food safety standards.

The firm received a Form FDA 483a, FSVP Observations, at the conclusion of both inspections but has not submitted a response to the most recent one. Failure to promptly correct these violations may result in refusal of admission of imported foods under section 80