FDA WARNING_LETTER - VHRK Food Inc. - August 26, 2021

On August 25-26, 2021, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of VHRK Food Inc., following a previous inspection from January 21 to February 16, 2021. The inspections aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR Part 1 Subpart L, which mandate importers perform risk-based activities to verify imported food meets U.S. safety standards.

The inspection revealed VHRK Food Inc. is not in compliance with FSVP requirements. A significant violation identified was the failure to develop, maintain, and follow an FSVP for any imported foods, including those from a specific foreign supplier. This violates 21 CFR 1.502(a) and Section 805 of the FD&C Act.

VHRK Food Inc.'s September 9, 2021, response to the FDA 483a indicated plans to notify vendors, obtain certifications, maintain records, and register for FSVP training. However, the FDA found the response inadequate due to a lack of specific documentation regarding FSVP implementation, copies of FSVPs, or a timeline for completing these activities.

Failure to adequately address these violations may lead to further FDA action, including refusal of admission for imported food products under Section 801(a)(3) of the FD&