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Preparation & Support

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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  • All Regulated Industries
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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

Factory workers in masks and protective uniforms inspecting and sorting cosmetic products on a production line in a clean manufacturing facility.
News

FDA Cosmetics Inspection: What the Draft Guidance on Records Access Means for Manufacturers

The FDA’s new draft guidance on records access marks a significant shift in cosmetics regulation under MoCRA. This comprehensive 2,500-word guide analyzes what these changes mean for manufacturers. We explore mandatory records requests, safety substantiation audits, and how to prepare for an FDA cosmetics inspection. Learn to navigate the new legal landscape and ensure your facility remains compliant with federal standards.

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February 22, 2026 No Comments
Manufacturing workers in masks and hairnets operating a clean production line in a cosmetic or pharmaceutical facility.
Inspections

Common Deficiencies Cited in FDA Cosmetic Inspections and How to Avoid Enforcement Actions

Navigating the complexities of modern beauty regulations requires a deep understanding of current FDA cosmetic inspections. This 2,500-word guide analyzes the most frequent deficiencies cited in recent reports, ranging from MoCRA registration failures to safety substantiation gaps. Discover professional strategies to strengthen your quality systems and maintain total regulatory compliance.

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February 22, 2026 No Comments
Food quality control workers in lab coats and masks inspecting packaged meals and fresh produce on a processing line with quality control screens.
Inspections

FSMA Risk-Based Inspection Frequency: What Food Processors Need to Know in 2026

Navigating the complexities of FSMA risk-based inspection frequency is vital for modern food processors. In 2026, the FDA utilizes sophisticated data analytics and facility history to determine audit timing. This 2,500-word guide explores how high-risk and non-high-risk designations impact your operations. Learn to improve your compliance profile, manage preventive controls, and maintain inspection readiness to ensure your facility meets federal safety standards effectively.

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February 22, 2026 No Comments
Quality control technician in a lab coat and hairnet reviewing a cosmetic jar in a laboratory, with product packaging on a clean workbench.
Warning Letters

Cosmetic Labeling Violations from Recent FDA Inspections and Warning Letters (2025-2026)

The Modernization of Cosmetics Regulation Act (MoCRA) has transformed how the FDA monitors the beauty industry. This comprehensive guide analyzes recent cosmetic labeling violations found in 2025-2026 warning letters. Learn about unauthorized drug claims, ingredient listing errors, and safety substantiation gaps. Stay compliant with evolving FDA standards and protect your brand from costly enforcement actions.

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February 22, 2026 No Comments
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Inspections

How to Prepare for FDA Data Integrity Inspections in Drug Manufacturing in 2026

Modern drug manufacturing relies on the accuracy and reliability of digital and manual records. This guide explores how to prepare for FDA data integrity inspections in 2026. We cover ALCOA+ principles, audit trail reviews, and system validation. Learn to identify vulnerabilities in your data lifecycle and implement corrective actions to ensure total compliance and patient safety.

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February 22, 2026 No Comments
Food safety inspector in a lab coat and hairnet checking meat temperature with a probe in a refrigerated display while holding a clipboard.
Inspections

FDA Food Facility Inspection Observations: Top Preventive Control Violations from Recent Reports

Managing food safety requires a deep understanding of current regulatory trends. This guide analyzes the most frequent FDA food facility inspection observations related to preventive controls. From hazard analysis failures to sanitation gaps, we break down what recent reports reveal about industry non-compliance. Learn actionable steps to strengthen your food safety plan and ensure audit readiness.

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February 22, 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.

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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
  • Staff Training
  • Documentation
  • Emergency Support

Industries

  • Pharmaceuticals
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  • Biotechnology
  • Food & Beverage
  • Cosmetics
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