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

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

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Industries We Serve

Biologics

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Cosmetics

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Dietary Supplement

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Medical Devices

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FDA inspection readiness services

Pet Food & Animal Health

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Pharmaceuticals

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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.

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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

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Our Blogs

A medical compliance expert discussing QMSR audit questions and documentation with a medical device manufacturer.
Inspections

QMSR audit questions for inspection program readiness

Transitioning to the Quality Management System Regulation (QMSR) requires a deep understanding of new FDA expectations. This guide provides critical QMSR audit questions to evaluate your inspection program readiness. From risk management to document control, learn how to bridge the gap between legacy systems and modern compliance standards to ensure a successful audit outcome.

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February 18, 2026 No Comments
Medical professionals using high-tech digital monitoring and diagnostic displays to ensure medical device quality and patient safety during a clinical assessment.
Inspections

common gaps in medical device inspection programs under QMSR

The transition to Quality Management System Regulation (QMSR) has exposed several common gaps in medical device inspection programs. From inadequate risk management to poor documentation, these failures can lead to FDA 483s. This guide explores how manufacturers can identify these gaps and strengthen their compliance posture to ensure audit success.

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February 18, 2026 No Comments
A professional doctor or compliance auditor explaining regulatory documentation and QMSR audit readiness requirements to a medical device manufacturer representative.
Inspections

QMSR audit readiness tips for medical device inspection programs

Transitioning from QSR to QMSR is a pivotal shift for medical device manufacturers. This comprehensive guide provides expert QMSR audit readiness tips to ensure your quality management system meets the new FDA requirements. From risk management to document control, discover how to streamline your inspection program and maintain global compliance.
Category: Inspections

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February 18, 2026 No Comments
Female auditor with a clipboard observing a masked technician examining a medical device in a manufacturing facility.
Inspections

Common FDA Audit Findings in Medical Devices and How to Avoid Them

Facing an FDA inspection can be daunting for any medical device manufacturer. A single Form 483 observation can lead to significant delays, costs, and reputational damage. This article provides an in-depth analysis of the most common FDA audit findings in medical devices. We dissect recurring issues in CAPA, complaint handling, and design controls, offering a proactive roadmap to not only pass your next inspection but to build a more robust and compliant Quality Management System.

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September 27, 2025 No Comments
Man in a suit working on a laptop with a compliance checklist and a monitor showing a digital security icon, representing FDA compliance risks in automation.
Inspections

Automation vs. Compliance: Managing FDA Risks in Digital Systems

In the life sciences, automation promises unprecedented efficiency and precision. However, every digital system introduces a new landscape of regulatory challenges. This article provides a comprehensive guide to identifying and managing the top FDA compliance risks in automation. From the complexities of software validation and data integrity under 21 CFR Part 11 to the rise of AI and the shift toward Computer Software Assurance (CSA), we provide a framework for ensuring your technology is an asset, not a liability.

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September 27, 2025 No Comments
Auditor holding a checklist clipboard during a GMP audit at a dietary supplement manufacturing facility.
Inspections

Dietary Supplement GMP Audit Checklist for New Manufacturers

Entering the dietary supplement market? Your success hinges on compliance with Good Manufacturing Practices (GMP). Failing an FDA inspection can lead to warning letters, recalls, and severe business disruption. This comprehensive dietary supplement GMP audit checklist provides a step-by-step roadmap for new manufacturers. We break down every critical area of 21 CFR Part 111—from personnel and plant conditions to production controls and record-keeping—to help you build a robust quality system from day one.

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September 27, 2025 No Comments

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

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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
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  • CAPA Development
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  • Documentation
  • Emergency Support

Industries

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  • Medical Devices
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  • Cosmetics
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