FDA 483 - Harvest Commodities Marketing, Inc. - December 20, 2023

Harvest Commodities Marketing, Inc. in Ardsley, NY, was inspected regarding its Foreign Supplier Verification Program (FSVP) and received four observations. The inspection revealed significant deficiencies, including the failure to develop an FSVP for psyllium husk, inadequate foreign supplier verification activities, and a lack of documented reevaluations of suppliers. This inspection highlights severe non-compliance with FSVP regulations, with one observation being a repeat finding.