483
Sojitz Corporation of AmericaFDA 483 - Sojitz Corporation of America - August 11, 2023
Record Details
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.
View Company Profile
ID · 08b40a6d-6012-4a94-80ae-329ddbd7e5bc
Other documents for Sojitz Corporation of America
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.