Ensuring Compliance: Your Path to FDA Readiness
Navigating the FDA's dietary supplement regulations can be complex. Our compliance investigator audit services are designed to help manufacturers, packers, labelers, and distributors meet CGMP standards and avoid costly enforcement actions. Let us guide you through the process and secure your business operations and brand reputation.
Who We Help
We work with manufacturers, own label distributors (OLDS), packagers, labelers, and warehouse facilities to ensure compliance with 21 CFR Part 111. The FDA targets any firm introducing dietary supplements into U.S. commerce, and so do we! Our audits focus on quality control, specifications, manufacturing operations, documentation, and personnel training. We prepare you for FDA scrutiny.
Mitigating Regulatory Risk
Our audit services solve the core problem of non-compliance with Current Good Manufacturing Practices (cGMP) and other FDA regulations, which can lead to severe enforcement actions. We proactively identify and correct issues before an official FDA inspection, helping you avoid costly enforcement actions, ensure product quality and safety, establish "inspection readiness", and drive continuous improvement.
Ready to Get Started?
Secure your initial FDA compliance review for just $250. Take the first step to full FDA compliance risk-free. If you aren't 100% sure what you need, we offer a low-friction way to get clarity.
"The audit services provided by [[name]] were invaluable. They helped us identify and correct critical compliance gaps, preventing potential FDA enforcement actions. We now feel confident in our ability to meet regulatory standards."
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