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GMP & FDA Compliance Resources

Practical tools built for dietary supplement manufacturers. Download free — no purchase required.

What's Inside Each Resource

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Self-Assessment Tool

21 CFR Part 111 Compliance Checklist

A complete, requirement-by-requirement self-assessment for dietary supplement GMP compliance. Maps to every section of FDA's 21 CFR Part 111.

  • 11 sections, 100+ checkpoints
  • FDA's most-cited warning letter violations
  • Risk scoring and remediation guidance
  • Print-ready format for facility use
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Emergency Response Guide

Warning Letter Response Playbook

A step-by-step 90-day response framework for dietary supplement companies that receive an FDA warning letter. Don't navigate this alone.

  • Day-by-day action plan (Days 1–90)
  • Written response structure FDA expects
  • 5 mistakes that make warning letters worse
  • Pre-submission response checklist
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Audit Preparation

GMP Audit Preparation Guide

A structured 90-day preparation plan for FDA inspections and third-party certifications (NSF 455-2, USP, UL/GMP). Be ready before they walk through the door.

  • Month-by-month preparation timeline
  • Mock inspection interview questions
  • NSF 455-2 specific preparation guidance
  • Inspection day protocol and record list
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200+
Companies certified
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Certification success rate
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Serving supplement manufacturers

Need More Than a Checklist?

If your assessment reveals gaps — or if you already have an FDA warning letter — let's talk. A free 30-minute call can clarify your situation and your fastest path forward.

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