FDA 483 - SOHGAVE LLC - April 30, 2024

This 483 report details significant deficiencies in OHMGAVE LLC's Foreign Supplier Verification Program (FSVP) for imported agave and coconut syrup products. Observations include a repeat finding for failing to evaluate foreign suppliers, lack of documented verification activities, and inadequate written procedures. The firm also failed to identify chemical hazards in its analysis and did not properly provide importer information during customs entry.