What FDA Inspection Data Reveals About FSVP Compliance
To ensure that importers are meeting their responsibilities under the FSVP rule, the FDA conducts inspections and reviews of importer compliance. During these inspections, FDA investigators evaluate whether importers have properly developed and implemented their FSVP programs. When deficiencies are identified, FDA documents them as citations under the FSVP rule.
To better understand common violations, the FIC chart below shows 10,845 FSVP inspection citations extracted from the FDA Data Dashboard “Inspection Details” dataset.