The Importance of Internal Auditing for FSMA Compliance: Ensuring Your Supplement Brand Stays Market-Ready

The Food Safety Modernization Act (FSMA) has transformed how food and dietary supplement brands must manage food safety and quality. One of the most critical aspects of compliance is having a robust internal auditing program to identify risks, ensure compliance, and prevent costly regulatory issues.

In this post, we’ll explore why internal auditing is essential for FSMA compliance and what makes a strong auditing program.

Why Internal Auditing Matters for FSMA Compliance

Internal audits are a proactive approach to compliance—they help identify gaps before the FDA or a third-party auditor does. A strong internal audit program ensures that:

Your Food Safety Plan Is Effective – FSMA requires Hazard Analysis and Risk-Based Preventive Controls (HARPC) to prevent contamination. Regular audits verify that preventive controls are working.

You Are Ready for FDA Inspections – The FDA has increased its inspections of dietary supplement companies. Internal audits help you stay ahead of potential violations.

Supplier Verification Meets FSVP Requirements – If you import ingredients or finished products, FDA's Foreign Supplier Verification Program (FSVP) requires proper documentation and oversight. Audits confirm that suppliers meet safety and compliance standards before issues arise.

Compliance with cGMPs Is Maintained – FSMA works alongside Current Good Manufacturing Practices (cGMPs) to ensure consistent product quality and safety. Internal audits help detect deviations, mislabeling, or contamination risks.

What Constitutes a Strong Internal Auditing Program?

A well-structured internal audit program should include the following key elements:

1. Defined Audit Scope & Objectives

Your audit should have a clear focus:

• Are preventive controls being followed?

• Are sanitation and allergen controls effective?

• Are batch records and supplier documents in compliance?

2. Risk-Based Audit Planning

Prioritize high-risk areas like raw material testing, supplier verification, and finished product release. FSMA emphasizes a risk-based approach, so your audit program should focus on where contamination or compliance failures are most likely to occur.

3. Trained Auditors with a Compliance Focus

Internal auditors must be trained in cGMPs, food safety, and hazard-analysis and preventive controls to effectively identify risks. They should know how to review documentation, interview staff, and inspect production areas for non-conformities.

4. Corrective and Preventive Actions (CAPA)

An audit is only effective if findings are addressed and corrected. A strong program includes:

✔ Root cause analysis for each issue found

✔ Corrective action plans with clear timelines

✔ Follow-up audits to verify resolution

5. Proper Documentation & Recordkeeping

FSMA requires detailed records, and audit findings must be properly documented in case of an FDA inspection. Audit reports should include:

✔ Non-conformities & observations

✔ Corrective action plans

✔ Supporting evidence (photos, test results, SOPs)

How We Can Help

At AMS Consulting Group we specialize in FSMA compliance and internal audit programs for dietary supplement brands. Our expert-led audits help you:

✅ Identify compliance gaps before FDA inspections

✅ Ensure supplier qualification and FSVP compliance

✅ Strengthen cGMP and food safety practices

✅ Develop CAPA plans that prevent recurring issues

Don't wait until an inspection exposes compliance risks—be proactive!