FDA WARNING_LETTER - Xin Ao International Group Corp. / Xin Ao Properties Usa Lius Group - May 06, 2025

On June 6, 2025, the FDA issued a Warning Letter to Xin Ao International Group Corp. following a Foreign Supplier Verification Program (FSVP) inspection conducted from April 23 to May 6, 2025, at their Staten Island, NY location. A previous inspection was also conducted from May 18-22, 2023. The inspection found the company non-compliant with section 805 of the FD&C Act and 21 CFR part 1, subpart L, which requires importers to perform risk-based activities to verify imported food meets U.S. food safety standards.

The primary violation identified was the failure to develop, maintain, and follow an FSVP for any imported foods, specifically citing Seafood Mushroom and Enoki Mushroom from unnamed foreign suppliers. An FDA Form 483a FSVP Observations was issued on May 6, 2025, to which no response has been received.

Failure to address these violations may result in refusal of admission for imported food under section 801(a)(3) of the FD&C Act, placement on detention without physical examination (DWPE) via Import Alert #99-41, and prohibition of importation under section 301(zz) of the FD&C Act. Xin Ao International Group Corp. must respond in writing within fifteen working days, detailing corrective actions, providing supporting documentation,