FDA WARNING_LETTER - IDC USA INC - February 24, 2021

On June 21, 2021, the FDA issued a Warning Letter to IDC USA Inc. following remote Foreign Supplier Verification Program (FSVP) inspections conducted from December 3, 2020, to February 24, 2021, and a prior inspection on February 26, 2019. The inspections aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L.

The FDA found significant violations for imported dried longan and dried dates from a supplier in (b)(4), and dried fungus from a supplier in (b)(4). Specifically, IDC USA Inc. failed to develop, maintain, and follow an FSVP for dried longan and dried dates, as required by 21 CFR 1.502(a). Additionally, the firm did not conduct a written hazard analysis for dried fungus to determine hazards requiring control, violating 21 CFR 1.504. While some documents were provided, the firm did not document its review and assessment of these, nor did it adequately evaluate foreign supplier performance or conduct appropriate verification activities.

The FDA noted that failure to address these violations could lead to 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) via Import Alert #99-