Our Compliance Framework
Our services are built on a structured framework that aligns with FDA mandates and industry best practices. Here's how we keep your business inspection-ready and protected:
1. FSVP Rule Compliance (21 CFR 1.500–1.514)
We help importers fully comply with the FSVP Final Rule by managing the required activities, documentation, and monitoring under a Qualified Individual (QI).
Key Elements We Address:
- Supplier risk evaluation based on product and process
- Foreign supplier performance assessments
- Verification activities (e.g., third-party audits, sampling/testing)
- Corrective action planning
- Records retention and audit readiness
2. U.S. Agent Compliance
As your designated U.S. Agent, we meet the FDA’s regulatory requirement for a domestic representative
who can act as the official liaison for foreign facilities. We ensure that:
- Your facility registration includes accurate U.S. Agent data.
- FDA communications are received and responded to promptly.
- Inspection coordination and emergency notifications are handled efficiently
3.Preventive Controls & QI Oversight
We assign FDA-trained Qualified Individuals (QI) to oversee your compliance program. These professionals are certified under the FSPCA curriculum and are experienced in conducting hazard analyses and verification activities required under FSMA.
4. Recordkeeping & Documentation Integrity
We maintain all essential FSVP records in secure digital formats accessible for FDA review upon request. This includes:
- Supplier evaluation summaries
- Verification results
- Monitoring and re-evaluation records
- CAP logs and updates
- FDA inspection preparation reports
5. FDA Inspection Support & Response
If your business is subject to an FSVP inspection or foreign facility audit, we provide:
- Pre-inspection audit preparation
- Corrective action guidance
- Communication support during and after FDA inspections
- Development of written responses to FDA 483 observations or warning letters
6. Continuous Monitoring of Regulatory Updates
We actively monitor updates from:
FDA Food Safety Modernization Act (FSMA)
FSVP guidance documents
Import alerts and recalls
Registration and biennial renewal changes
This allows us to adapt your compliance program as regulations evolve.
Data Security And Confidentiality
As part of Consultare Inc. Group, our infrastructure adheres to strict data protection and confidentiality standards. All client records, communications, and sensitive business information are securely managed and protected.
Sample Compliance Deliverables
- FSVP Compliance Plan
- Supplier Verification Activity Matrix
- FDA Audit Readiness Report
- CAP (Corrective Action Plan) Documentation
- U.S. Agent Agreement Template
- FSVP Recordkeeping Logbook
Partner with a Compliance-Driven Team
Compliance isn’t optional—it’s your competitive edge. Partner with FSVPServices.com, powered by
Consultare Inc. Group, A Compliance Company, and take the guesswork out of FDA compliance.