Who must perform all foreign supplier verification program tasks?

• A. The importer
• B. A qualified individual
• C. FDA
• D. A certified auditor

Answer: (B)

The task signals who is legally equipped to carry out the responsibilities of the Foreign Supplier Verification Program. The regulation requires that all FSVP tasks be performed by a qualified individual—someone with the education, training, or experience to carry out hazard analysis, determine and implement appropriate verification activities, review supplier performance, and maintain the records. The importer holds the ultimate responsibility for compliance, but the actual FSVP work must be done by this qualified person. FDA does not perform these tasks, and while audits or external help can support the process, they don’t replace the need for a qualified individual to perform and attest to the FSVP activities.