FDA WARNING_LETTER - K2 TRADING INC. - May 25, 2022

On May 4-25, 2022, the FDA inspected K2 TRADING INC. at 140 Hobart Street, Hackensack, NJ, following a previous inspection from February 19 to March 9, 2021. The inspections assessed compliance with the Foreign Supplier Verification Program (FSVP) regulation (21 CFR part 1, subpart L) under section 805 of the FD&C Act.

During the recent inspection, K2 TRADING INC. provided FSVP records for dried seaweed, wheat flakes, and boiled royal fern. However, the firm acknowledged not developing FSVPs for other imported foods identified by the investigator between May 1, 2021, and April 30, 2022.

The primary violation cited is the failure to develop, maintain, and follow an FSVP, as required by 21 CFR part 1.502(a) and section 805 of the FD&C Act. Specifically, the firm did not have an FSVP for various imported foods.

A Form FDA 483a FSVP Observations was issued on May 25, 2022, but no response has been received. Failure to adequately address these violations may result in refusal of admission for imported food under section 801(a)(3) of the FD&C Act, potential detention without physical