FDA Inspection Consulting | Mock Audits & Remediation Experts

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FDA Inspections

Consulting and Compliance

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.

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

Industries We Serve

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.

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

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

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

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.

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.

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.

September 27, 2025 No Comments

Woman in a navy blazer reviewing and signing documents at her desk with a laptop and binder.

Inspections

How to Prepare for a Pre-Approval FDA Inspection Without the Panic

The Pre-Approval Inspection (PAI) is the final hurdle between your product and the market. The stakes are immense, and panic is a common reaction. But what if you could replace that anxiety with confidence? This guide details how to prepare for a pre-approval inspection by focusing on a proactive, three-pronged strategy: fortifying your Quality Management System, ensuring data integrity, and training your team for success. We provide actionable steps to ensure you are ready for FDA scrutiny.

September 27, 2025 No Comments

Woman in a lab coat reviewing a checklist on a clipboard at a desk with a laptop, symbolizing a mock FDA audit preparation.

Inspections

Do You Need a Mock FDA Audit? Benefits and What to Expect

The thought of an unexpected FDA inspection can keep any life sciences leader awake at night. A single misstep can lead to warning letters, product delays, and lost credibility. So, how can you pressure-test your systems before the real thing? This article explores the critical role of mock FDA audits. We detail the immense benefits, what to expect during the process, and how to select the best FDA inspection mock audit services to ensure your company is truly prepared for regulatory scrutiny.

September 27, 2025 No Comments

Woman in a lab coat reviewing documents on a clipboard at a desk with a laptop, preparing for an FDA inspection.

Inspections

FDA Inspection Preparation Guide for Life Sciences Startups

For a life sciences startup, the first FDA inspection is a pivotal moment that can define its future. Inadequate preparation can lead to costly delays, warning letters, and a loss of investor confidence. This guide provides a comprehensive roadmap for FDA inspection preparation for startups. We cover everything from establishing a robust Quality Management System (QMS) and training your team to managing the inspection in real-time and handling post-inspection communications. Prepare to meet regulatory scrutiny head-on.

September 27, 2025 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.

If you’ve received an FDA inspection notice, don’t panic. Our rapid response team can help you prepare quickly and effectively.

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.

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