FDA WARNING_LETTER - V-Nine Inc. - June 29, 2020

On June 10 and 29, 2020, the FDA conducted a remote Foreign Supplier Verification Program (FSVP) inspection of V-Nine Inc., located at 2130 Beaver Road, Hyattsville, Maryland, following a previous inspection on April 10 and 18, 2018. The inspections assessed compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L, which mandate risk-based activities for importers to ensure food safety.

The FDA found V-Nine Inc. non-compliant with FSVP requirements for imported pad thai sauce and jasmine rice. Specifically, the firm did not develop an FSVP for pad thai sauce. For jasmine rice, while a hazard analysis was obtained from the foreign supplier, V-Nine Inc. failed to document its review and assessment as required by 21 CFR 1.504(d). The firm also did not document approval of the foreign supplier based on performance and risk evaluation (21 CFR 1.505(b)), nor did it establish written procedures or document the determination of appropriate supplier verification activities (21 CFR 1.506(b) and (d)).

These significant violations mean V-Nine Inc. is not in compliance with section 805 of the FD&C Act. The FDA acknowledged the firm's July 16, 20