Our Approach
Services
FSVP Agent Service (FSVP Importer)
Full FSVP oversight, ongoing management, and FDA representation
We manage your full FSVP on an ongoing basis, keeping documentation current, monitoring suppliers, and maintaining the records FDA expects to see. We act as the designated FSVP Importer in FDA systems, using our U.S. address and DUNS for entry filings. This service is designed for importers who want reliable compliance oversight without building an internal regulatory team.
What’s included
- Ongoing review of supplier documentation, certificates, audits, and test results
- Monitoring of recalls, import alerts, and relevant FDA updates
- Annual or risk-based re-evaluations of suppliers
- Maintenance and updates of each FSVP plan
- Corrective-action tracking and follow-up
- Communication with suppliers to gather missing or updated materials
- Organization and upkeep of your FSVP documentation in the United States
- Full FSVP Agent coverage, including FDA communication and the use of our U.S. address and DUNS number for all FSVP entry filings (when we are designated as the FSVP Importer).
Deliverables You Receive
- A fully maintained, inspection-ready FSVP
- Updated supplier files and verification records throughout the year
- Monitoring reports and alerts when new information affects risk
- Structured corrective-action logs and supplier review summaries
- A consistent point of contact for suppliers and FDA correspondence (if agent service is added)
- Quarterly FSVP review meetings to keep documentation current and aligned with FDA expectations
- Up to 10 hours of annual advisory support for documentation updates, supplier changes, or FDA-related questions
- Gap summaries outlining what needs to be corrected and how
- Corrective-action recommendations with practical next steps
How This Supports Compliance
FSVP is not a one-time requirement. FDA expects importers to update files, reassess suppliers, and maintain current documentation. Ongoing implementation and timely verification activities ensures your program stays aligned with FDA expectations and reduces the likelihood of gaps during inspections or record requests.
Request a Quote
We can outline ongoing support based on your number of suppliers, products, and risk level.