FDA WARNING_LETTER - Handylee USA Corp. - July 07, 2020

The FDA conducted a remote Foreign Supplier Verification Program (FSVP) inspection at Handylee USA Corp. from June 18 to July 7, 2020, following an earlier inspection in 2017. The inspection aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L. The firm was found non-compliant, lacking FSVPs for all imported food products, including canned corn, mushrooms, and bamboo. Significant violations include the failure to develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Additionally, the firm failed to verify and document that thermally processed low-acid canned foods were produced in accordance with 21 CFR part 113, as mandated by 21 CFR 1.502(b)(1). The firm also failed to respond to the Form FDA 483a issued on July 7, 2020. The FDA emphasized the need to conduct hazard analyses (21 CFR 1.504), evaluate foreign supplier performance (21 CFR 1.505), and consider hazards when determining verification activities (21 CFR 1.506) to achieve compliance. Handylee USA Corp. must take prompt corrective action and submit a written response within fifteen working days, including documentation of corrections. Failure to comply may result in refusal of admission, detention without physical examination (DWPE), and prohibition of importation under section 301(zz) of the FD&C Act.