FDA WARNING_LETTER - UCC Ueshima Coffee Company America Inc. - September 11, 2020

On January 29, 2021, the FDA issued a Warning Letter to Mr. Jay S. Egami following a Foreign Supplier Verification Program (FSVP) inspection conducted from August to September 2020, and a previous inspection in May 2018. The inspections assessed compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L.

The FDA found significant violations, specifically that the firm did not have FSVPs for imported UCC black coffee, UCC green tea (both ready-to-drink from (b)(4)), and UCC Hawaii Kona coffee (ready-to-drink from (b)(4)). This violates 21 CFR 1.502(a). Additionally, for these low-acid canned foods, the firm failed to verify and document that they were produced in accordance with 21 CFR part 113, as required by 21 CFR 1.502(b)(1).

The FDA acknowledged the firm's responses to Form FDA 483a, including intent to work with a consultant and a list of milestones, but could not fully evaluate them due to a lack of written procedures, documentation of corrections, or progress reports.

The letter mandates prompt corrective action. Failure to comply may result in refusal of admission for the imported products under section 801(a)(3) of the FD&