https://fdaspecialist.com/what-happens-if-you-fail-an-fsvp-inspection-fda-483s-warning-letters-and-import-alert
What Happens if You Fail an FSVP Inspection: FDA 483s, Warning ...
FDA is now placing importers on the Red List of Import Alert 99-41 ... importer, listing all the investigator's observed violations of the FSVP regulation.