FDA Audit
Stay Compliant. Stay Confident.
Prepare Smarter. Nail Inspections
Is your organization prepared for an FDA inspection? At FDAMap, we specialize in providing comprehensive FDA audit services to pharmaceutical, biotech, and medical device companies worldwide. With a strong track record of more than 100 successful audits across GCP, GMP, GLP, and GACP standards, we’re here to ensure your FDA readiness from day one.
What We Offer
End-to-End FDA Audit Support
Our team of FDA regulatory experts offers full-spectrum audit services, including:
- Internal & third-party audits
- Mock FDA inspections
- Gap assessments & CAPA recommendations
- GMP, GCP, GLP compliance evaluation
SOP Development & Training Programs
We don’t just audit—we help build a sustainable quality culture.
- SOP drafting tailored to FDA expectations
- Onsite and virtual staff training in GMP, QA, QC, and inspection readiness
- Customized workshops for audit preparedness
Audit Support from Start to Finish
From the first audit announcement to post-inspection support, we’ve got you covered.
- On-site support during FDA inspections
- Expert handling of FDA investigator queries
- FDA 483 and warning letter response preparation
- Follow-up audit planning and remediation tracking
Compliance Monitoring That Goes Beyond the Audit
Ensure continued FDA compliance through ongoing support:
- Adverse event reporting & safety monitoring
- Product traceability & accountability
- Protocol violation tracking & resolution
- Clinical investigator & CRO oversight
- Lab data review & financial disclosure compliance
Team up with our experts for FDA audit readiness
Connect with us today to discover how our 20 years of FDA success can guide you in your next FDA audit
Why Choose Us?
- Global Experience: 100+ audits completed across the U.S., Europe, Asia & South America
- Seasoned Experts: Consultants with decades of FDA regulatory experience
- Mock Inspections: Real-world practice that improves audit outcomes
- Proven Results: Clients who trust us return prepared, confident, and audit-ready
