Is Your Dietary Supplement Facility Truly FDA-Ready? A Compliance Checklist

The FDA’s increased scrutiny of dietary supplement facilities means preparation is no longer optional—it’s essential. A surprise inspection can uncover costly compliance gaps, leading to 483s, warning letters, or even facility shutdowns.

But how do you ensure your facility is audit-ready before the FDA arrives? This guide breaks down key compliance requirements and how a Pre-FDA Gap Assessment can safeguard your business.

Why FDA Compliance Matters More Than Ever

The FDA has ramped up inspections under FSMA, cGMP (21 CFR 111), and dietary supplement regulations, focusing on:

Documentation & SOPs – Are they complete and followed?
Facility Conditions – Is production hygienic and well-controlled?
Ingredient Safety – Is your supply chain FSVP-compliant?
Labeling & Claims – Are they truthful and non-misleading?

Non-compliance risks:

• FDA Form 483 observations (publicly available)
• Warning letters (damaging to reputation)
• Import bans (for foreign facilities)
• Legal action or recalls

Pre-FDA Compliance Review: Your Best Defense

A simulated FDA inspection helps uncover gaps before they become violations. Here’s what it covers:

1. cGMP Audit (21 CFR 111)
- • Manufacturing controls (batch records, equipment sanitation)
- • Testing & quality assurance (raw materials, finished products)
- • Personnel training (are employees following SOPs?)
2. FSVP (Foreign Supplier Verification Program)
- • Supplier qualification (are foreign ingredients safe and compliant?)
- • Risk assessments (do you have documentation for every import?)
3. Label & Claim Compliance
- • FDA & FTC regulations (no unauthorized disease claims)
- • Proper ingredient listing (no hidden or synthetic additives)
4. Mock FDA Inspection
- • Interview staff (do they understand protocols?)
- • Review records (are they complete and retrievable?)
- • Facility walkthrough (are storage & production areas compliant?)

How to Prepare Now

Conduct a self-audit using FDA’s Dietary Supplement cGMP Checklist

Train employees on SOPs and documentation best practices

Schedule a Pre-FDA Gap Assessment (like a "practice inspection")

Need Expert Help?

FSVP Services offers FDA-mimicked inspections to identify risks and fix them before regulators do.

Get a FREE Compliance Consultation:

Visit FSVPServices.com

Ready to Get Started?

Waiting for an FDA inspection to find your weaknesses is a costly gamble. Proactive compliance isn’t just about avoiding fines—it’s about protecting your brand and consumers.