FDA WARNING_LETTER - H & C Food Inc. - April 14, 2020

On April 9 and 14, 2020, the FDA conducted a remote Foreign Supplier Verification Program (FSVP) inspection of H & C Food Inc., following an initial on-site inspection on August 23, 2018. 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 ensure imported food meets U.S. safety standards.

H & C Food Inc. was found non-compliant for Enoki Mushroom from Green Co., Ltd, South Korea, and Teriyaki Kimnori Roasted Seaweed Snack, lacking required FSVPs for these products. This constitutes a significant violation of Section 805 of the FD&C Act. Form FDA 483a, FSVP Observations, was issued after both the 2018 and 2020 inspections.

The firm's May 4, 2020, email responses, including HACCP plans and other documents for the suppliers, were deemed inadequate as H & C Food Inc. did not provide their review or explain how these documents applied to their FSVP.

Specific violations include failure to conduct a hazard analysis (21 CFR 1.504), evaluate foreign suppliers' performance (21 CFR 1.505), and perform foreign supplier verification activities (21 CFR