J & L Usa Inc. – FDA Warning Letter, Jan 19, 2021

On January 19, 2021, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of J & L USA Inc. (Commerce, CA), following a previous inspection on May 31, 2019. The inspections assessed compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L, which mandate risk-based activities to verify imported food meets U.S. safety standards.

The firm was found non-compliant for not developing, maintaining, and following FSVPs for several imported food products. Specifically, J & L USA Inc. lacked FSVPs for Green Tea and Dried Bamboo Leaf from (b)(4), and Dried White Fungus from (b)(4). Additionally, the firm remained non-compliant for Rock Candy and Brown Candy in Pieces imported from (b)(4), issues identified in the prior inspection.

These significant violations of 21 CFR 1.502(a) mean the firm is not in compliance with section 805 of the FD&C Act. The FDA provided Form FDA 483a, FSVP Observations, after both inspections, but received no response.

Failure to adequately address these violations may lead to regulatory action, including refusal of admission for the implicated products under section 801(a)(3) of the FD&C Act, and potential detention without physical examination (DWPE