Our Approach to Fda Dietary Supplement Compliance

We're transforming fda dietary supplement compliance investigations with a proactive, data-driven approach. Learn how we ensure quality and regulatory adherence, setting a new standard in the industry.

Vast data processing

The dietary supplement industry produces enormous volumes of data (manufacturing logs, sops, adverse event reports, batch records, quality control results, etc.). Our ai/ml tools can ingest, process, and cross-reference this data instantaneously, something human investigators cannot do at scale. This empowers us to deliver more thorough and efficient compliance audits.

Targeted audits (risk-based approach)

By rapidly analyzing historical compliance data and real-time operational metrics, our ai-driven approach allows us to proactively identify high-risk areas or specific deviations. Instead of spending days manually reviewing documents, we focus the audit immediately on the most critical potential violations, such as inconsistencies in batch records, unreported patterns in adverse event data, and deviations from current good manufacturing practices (cgmps).

Success story: vitality blends

A mid-sized dietary supplement manufacturer, "vitality blends," received a notice for an upcoming fda inspection focused on their current good manufacturing practices (cgmp) under 21 cfr part 111. The qa manager, sarah, faced a critical challenge: incomplete or inconsistent raw material specifications. Our approach identified missing specifications for identity and purity for three new botanical ingredients, allowing sarah to rectify the issues proactively.

"Their ai-powered approach transformed our fda compliance process, saving us time and resources."

Sarah, Qa Manager at Vitality Blends

Ready to take the next step?

After learning about our approach, here's how you can further enhance your fda dietary supplement compliance:

  • Conduct a self-assessment against fda cgmp regulations (21 cfr part 111).
  • Develop or refine your company's protocol for handling fda inspections.
  • Seek expert guidance from our experienced consultants.