FDA WARNING_LETTER - hk produce group inc. - August 25, 2021

On January 5, 2022, the FDA issued a Warning Letter to HK Produce Group Inc. DBA Y2S Trading Inc. following a remote Foreign Supplier Verification Program (FSVP) inspection conducted from August 11 to August 25, 2021. The inspection was initiated due to FDA samples finding *Listeria monocytogenes* in four entries of fresh enoki mushrooms imported by the firm, three from one supplier and one from another. These suppliers' products were subsequently placed under Import Alerts #99-23 and #99-35.

The inspection revealed significant violations of the FSVP regulation (21 CFR part 1, subpart L) and section 805 of the FD&C Act. Specifically, the firm failed to develop, maintain, and follow an FSVP for any imported foods, including fresh enoki mushrooms from the identified suppliers. An FDA Form 483a FSVP Observations was issued, but no response has been received.

The FDA stated that failure to adequately address these violations could lead to refusal of admission for imported food under section 801(a)(3) of the FD&C Act, potential detention without physical examination (DWPE) under Import Alert #99-41, and prohibition of importation under section 301(zz) of the FD&C Act. The firm is required to respond in writing within fifteen working days, detailing