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Explore our success stories and discover how we've helped dietary supplement companies navigate the complex landscape of FDA compliance. From mitigating warning letters to preventing enforcement actions, our expertise ensures your business operates with confidence and avoids costly disruptions.
Navigating permanent injunctions and consent decrees
The most definitive success stories involve federal courts ordering companies to cease operations until they meet federal regulations.
Example: A federal court enters a Consent Decree of Permanent Injunction against a supplement distributor and manufacturer for failing to comply with multiple Current Good Manufacturing Practice (CGMP) requirements (21 CFR Part 111). This action stops the distribution and manufacturing of the products until the company proves it can operate in full compliance.
Preventing or successfully navigating fda action
These stories show you have the expertise to protect clients from the most severe consequences of non-compliance.
Warning letter mitigation
Example: "Reduced the time-to-close on a critical FDA Warning Letter from an estimated 12 months to just 4 months by implementing a targeted QMS overhaul, preserving the client's largest sales channel."
483 inspection response excellence
Example: "Guided a client through their first-ever FDA inspection, resulting in only two minor 483 observations, and developed a robust response package that precluded any subsequent enforcement action."
