Available 24/7 for Urgent On-Site or Virtual Consulting

FDA Inspections

Consulting and Compliance
Contact Us

Expert FDA Inspection
Preparation & Support

Ensure your facility passes FDA inspections with confidence. Our experienced team provides comprehensive preparation, documentation review, and on-site support.

  • Ready for Your Next Inspection?

Don’t wait until the last minute. Our proactive approach ensures your facility is always inspection-ready.

Get Started Today
Schedule Meeting
View Our Services
  • AI and Automated Solutions
  • All Regulated Industries
  • Former FDA
  • 24/7 Emergency Support

Industries We Serve

Biologics

Learn More
An image of fda cosmetics inspections

Cosmetics

Learn More
An image of FDA dietary supplement inspections

Dietary Supplement

Learn More
An image of medical devices FDA inspections

Medical Devices

Learn More
FDA inspection readiness services

Pet Food & Animal Health

Learn More
Image of Pharmaceutical FDA Inspections

Pharmaceuticals

Learn More

Comprehensive FDA Compliance Services

From preparation to post-inspection support, we provide end-to-end solutions to ensure your facility meets all FDA requirements and maintains compliance.

Pre-Inspection Preparation

Comprehensive facility audits, documentation review, and gap analysis to ensure complete readiness.

On-Site Inspection Support

Expert consultants present during inspections to provide guidance and ensure smooth interactions with FDA officials.

CAPA Development

Corrective and Preventive Action plan development for addressing inspection findings and preventing recurrence.

Training Programs

Staff training on FDA regulations, GMP compliance, and inspection preparedness for your entire team.

Documentation Systems

Design and implementation of robust documentation systems that meet FDA requirements and best practices.

24/7 Emergency Support

Round-the-clock support for urgent compliance questions and emergency inspection notifications.

  • Need a Custom Solution?

Every facility is unique. We provide tailored consulting services to address your specific compliance challenges and regulatory requirements.

Discuss Your Needs

Your Trusted Partner in

FDA Compliance

With over 15 years of experience in FDA regulatory compliance, our team of former FDA inspectors and industry experts has helped hundreds of facilities successfully navigate complex regulatory requirements.

We understand the challenges you face because we’ve been there. Our practical, results-driven approach ensures your facility not only passes inspections but maintains ongoing compliance excellence.

  • Former FDA inspectors on our team with insider knowledge
  • Proven methodologies tested across diverse industries
  • Ongoing support to maintain compliance between inspections
  • Expert Team

Our team brings decades of combined experience from both regulatory and industry perspectives.

500+

Facilities Served

100%

Success Rate

15+

Years Experience

24/7

Support Available

Our Blogs

Three professionals in business attire sit around a conference table, reviewing documents and preparing for an FDA QMSR Inspection Program Audit. A whiteboard behind them lists key topics like Quality System Regulations (QSR), ISO 13485 standards, gap analysis, and mock audits.
Inspections

Preparing For FDA QMSR Inspection Program Audit

Preparing for an FDA QMSR inspection program audit requires a deep understanding of the new regulatory landscape. This 2026 guide covers everything from rule interpretation to the best tools for medtech compliance. Ensure your quality management system is ready for the transition from QSR to QMSR by identifying common challenges and implementing best practices for medical device audits.

Read More »
February 20, 2026 No Comments
An infographic outlining the steps to fix inspection program gaps in Quality Management System Reviews (QMSR), including identifying gaps, analyzing root causes, updating procedures, training staff, and monitoring progress for continuous improvement.
Inspections

How To Fix Inspection Program Gaps In QMSR

Identifying and closing inspection program gaps is critical for medical device manufacturers transitioning to the FDA’s Quality Management System Regulation (QMSR). This comprehensive guide explores technical strategies, risk-based methodologies, and best practices to ensure your internal audits align with ISO 13485:2016 and FDA expectations, preventing 483 observations and warning letters.

Read More »
February 20, 2026 No Comments
Medical tablet displaying health data with heart rate and blood pressure graphs, surrounded by a stethoscope, glasses, and papers on a desk.
Inspections

Common QMSR Inspection Program Challenges For Medtech

As the MedTech industry transitions from QSR to QMSR, manufacturers face significant operational hurdles. This guide explores the most common QMSR inspection challenges, focusing on risk management integration, ISO 13485 alignment, and data integrity. Learn how to identify systemic gaps and implement proactive solutions to ensure your quality management system remains compliant in 2026.

Read More »
February 20, 2026 No Comments
A scientist in a lab coat analyzes medical imaging data on multiple computer screens, displaying brain scans and diagnostic information in a high-tech lab setting.
Inspections

QMSR Medical Device Regulation Inspection Guidance Document

The transition to the FDA’s Quality Management System Regulation (QMSR) requires a new approach to compliance. This comprehensive guide explores the QMSR Medical Device Regulation Inspection Guidance document. Discover how the harmonization with ISO 13485:2016 impacts your audit strategy, risk management, and overall regulatory standing. Learn actionable steps to ensure your medical device QMS is ready for federal investigators in 2026.

Read More »
February 20, 2026 No Comments
A medical professional and technician reviewing a brain scan on a monitor while a patient lies on a medical examination table.
Inspections

Best Practices For Medical Device Inspection Program QMSR Compliance

Achieving seamless regulatory alignment requires a proactive strategy. This guide explores the essential best practices for medical device QMSR compliance, focusing on risk-based auditing and ISO 13485:2016 harmonization. Discover how to optimize your inspection program, leverage automation, and maintain an audit-ready quality management system to successfully navigate the evolving FDA oversight landscape in 2026.

Read More »
February 20, 2026 No Comments
A comparison of the QMSR and ISO 13485 inspection programs, featuring two professionals. On the left, an FDA auditor reviews a QMSR audit checklist, while on the right, a healthcare professional examines an ISO 13485 audit checklist. The background includes lab equipment and documentation relevant to each program.
Inspections

QMSR vs ISO 13485 Inspection Program Differences

As the FDA transitions to the Quality Management System Regulation, manufacturers must navigate the nuances of QMSR vs ISO 13485 inspection program differences. This guide provides a deep dive into regulatory harmonization, risk management expectations, and technical audit requirements to ensure your medical device quality system remains compliant with both federal and international standards in 2026.

Read More »
February 20, 2026 No Comments

Get Expert FDA Consultation

Don’t face your next FDA inspection alone. Contact our experts today for a confidential consultation and ensure your facility is ready.

  • Schedule Your Consultation
  • Contact Information
  • (555) 123-4567
    24/7 Emergency Line
  • [email protected]
    General inquiries
  • Washington, D.C.
    Serving facilities nationwide
  • Response Time
    Within 2 hours during business hours
  • Emergency Inspection Notice?
If you’ve received an FDA inspection notice, don’t panic. Our rapid response team can help you prepare quickly and effectively.
Emergency Support

FDA Inspections

Your trusted partner for FDA compliance and inspection readiness. With former ex-FDA’ers  on our team, we provide the expertise and confidence you need to succeed.

Services

  • Pre-Inspection Prep
  • On-Site Support
  • CAPA Development
  • Staff Training
  • Documentation
  • Emergency Support

Industries

  • Pharmaceuticals
  • Medical Devices
  • Biotechnology
  • Food & Beverage
  • Cosmetics
  • Clinical Research
© 2024 FDA Inspections. All rights reserved.
  • Privacy Policy
  • Terms of Service
  • Disclaimer
Scroll to Top