Verification is not one-size-fits-all. SafestSource offers desk audits, on-site audits, and
managed protection with QI oversight—all designed to reduce FDA exposure and keep your FSVP records defensible.
Do FDA FSVP rules require on-site foreign supplier audits?
FSVP requires risk-based supplier verification. Depending on hazard analysis and supplier risk, on-site audits may be appropriate or preferred—especially for higher-risk foods.
How do I know which package I need?
Essential fits mature or certified suppliers where document verification is sufficient. Advanced Verification is best when risk is higher or certification is absent and you need on-site evidence. Regulatory Shield™ is for multi-supplier operations that want ongoing oversight, monitoring, and inspection-day readiness.
Is this only an “audit service”?
No. We provide a verification program: desk audits, on-site audits, corrective action governance, and—under Regulatory Shield™—continuous monitoring with QI oversight so your FSVP system stays current between audits.
What deliverables do we receive?
Depending on the package, you receive an English verification summary (desk audit), an English on-site audit report with findings and evidence, and/or a managed compliance trail with monitoring logs, alerts, scorecards, and documented CAR closure.
Which countries do you cover for supplier audits?
We cover Mexico, Central America, and South America. If you have suppliers outside these areas, contact us—coverage can be expanded based on need.
How do you manage corrective actions and follow-up?
We use AuditSuit to manage findings, attach evidence, and track corrective actions with deadlines and closure evidence—creating a centralized, defensible audit trail.
Can you audit packaging, labeling, or cold storage sites?
Yes. Verification can include processing, packing, holding, distribution, and supporting activities based on your imported product chain and risk profile.
Do you provide bilingual communication with suppliers?
Deliverables for U.S. importer files are provided in English. We can support bilingual supplier coordination when needed.
Can SafestSource act as our FSVP Qualified Individual (QI)?
Yes. Under Regulatory Shield™, we provide external QI oversight and maintain defensible documentation tied to your hazard analysis and supplier verification activities.
Do you provide ongoing supplier monitoring?
Yes. We monitor supplier status, certification validity, compliance signals, and risk indicators as part of our managed protection model.
Do you monitor FDA Import Alerts and recalls?
Yes. We screen relevant Import Alerts and recall activity connected to your suppliers and products and document actions taken.
What happens if FDA contacts us?
Under Regulatory Shield™, we provide priority inspection-day support to help organize records and respond clearly and defensibly.
Is this only for Mexico suppliers?
No. While we specialize in Mexico and Latin America, our verification framework supports any foreign supplier relevant to your FSVP obligations.
How is this different from a normal FSVP audit?
A standard audit is transactional. Regulatory Shield™ is continuous protection with monitoring, QI oversight, and compliance continuity.
