FDA 483 - Sojitz Corporation of America - August 11, 2023

Sojitz Corporation of America received a Form 483 following an FDA inspection of its Foreign Supplier Verification Program (FSVP). The firm failed to develop and implement a proper FSVP, including critical procedures for hazard analysis, risk evaluation, supplier approval, verification, and corrective actions. Additionally, the company did not provide English translations for FSVP records maintained in a foreign language.