Supplement Manufacturer Audits

When you hire a contract manufacturer, you’re putting your brand’s reputation in their hands. They control product quality, documentation, and regulatory compliance — yet many supplement brands never take a close look inside the facility until something goes wrong.

The FDA expects supplement brand owners to qualify and monitor their contract manufacturers under 21 CFR 111. Retailers and distributors expect it, too. That means you can’t just assume your manufacturer is “GMP compliant” because they said so or because a certificate is hanging on the wall. The only way to know is through a proper audit.

At Blue Ocean Regulatory, we perform supplement manufacturer audits tailored to brand owners. We verify that your manufacturing partner is truly following FDA dietary supplement cGMPs — and we give you clear, actionable feedback you can actually use to manage the relationship.

Why Audits Are Essential

  • Regulatory obligation: The FDA requires supplement brand owners (even those who outsource 100% of manufacturing) to ensure their products are made under GMPs. You can’t outsource liability.

  • Retailer and investor expectation: Retailers like Amazon, Whole Foods, and Costco may request manufacturer audit reports before approving products. Investors want to know your supply chain is protected.

  • Risk prevention: Quality failures, cross-contamination, label misbranding, and failed testing often trace back to gaps in a manufacturer’s SOPs or controls. An audit catches those weaknesses before your customers or regulators do.

What Our Audits Cover

We go beyond a “GMP checklist audit.” Our approach blends regulatory requirements, practical brand-owner concerns, and risk-ranking to give you a complete picture.

1. Facility Walkthrough & Documentation Review

  • Sanitation, equipment, and environmental controls.

  • SOPs for production, cleaning, testing, and training.

  • Batch records, master manufacturing records, and change control systems.

  • Retention sample programs and recordkeeping.

  • Supplier qualification files for raw materials and excipients.

2. Testing & Quality Systems

  • Incoming raw material testing (identity, potency, contaminants).

  • In-process and finished product testing procedures.

  • Use of qualified third-party labs.

  • Handling of out-of-specification (OOS) results.

  • Stability testing protocols and shelf-life substantiation.

3. Personnel & Training

  • Review of staff training records.

  • Roles, responsibilities, and oversight of production and QC.

  • Handling of deviations and non-conformances.

4. Risk-Ranking & Gap Analysis

  • Identify critical vs. minor findings.

  • Rank issues by potential impact on compliance, quality, and consumer safety.

  • Provide a clear action plan so you can address weaknesses with your manufacturer.

Common Issues We Find

Many supplement founders assume their manufacturer is compliant because they’ve worked with other brands or show a certificate. But we routinely uncover issues such as:

  • Batch records missing required elements or improperly signed.

  • Incomplete supplier qualification files (no COAs or weak documentation).

  • Poor environmental monitoring or inadequate cleaning validation.

  • Procedures with little to no involvement or considerations for their customer (aka you).

  • Vulnerable facility design and people/ingredient traffic flow issues.

Even reputable facilities can have blind spots. An audit ensures your brand doesn’t share in the liability.

Tailored for Brand Owners

Traditional audits are often written for regulators or manufacturers — long, technical reports full of jargon. At Blue Ocean Regulatory, we design audits for you, the brand owner.

  • You’ll get a plain-language executive summary that highlights what matters most for your business.

  • Findings are prioritized, so you know what needs urgent action and what can be addressed later.

  • We provide a summary of their operations and fundamental testing protocols that you can share directly with your team to drive improvements.

  • If needed, we can support corrective action follow-up and re-audits.

On-Site or Remote Options

We offer both on-site manufacturer audits and remote desk audits:

  • On-Site Audits: A full, in-person review of the facility, staff, and processes. Best for long-term partners or high-risk products.

  • Remote Desk Audits: Review of SOPs, batch records, test results, and certifications. Best for early-stage qualification or during travel restrictions.

Both options are structured, documented, and aligned with FDA and retailer expectations.

Why Brands Choose Blue Ocean Regulatory

We understand the realities of working with contract manufacturers. Our audits are not about “catching” your partner or creating adversarial relationships. They’re about building trust, accountability, and transparency so your brand can grow on a stable foundation.

We’ve been featured in NutraIngredients USA, invited to guest speak at events hosted by the Council for Responsible Nutrition, and interviewed on The Nutracast Podcast — trusted voices in supplement compliance and quality.

Brands come to us because we make audits approachable, practical, and tailored to the needs of founders — not just regulatory auditors.

Next Steps

If you’ve never audited your manufacturer, or if your last audit was more than a year ago, now is the time. Regulators, retailers, and investors expect you to actively monitor your supply chain.

Schedule a Supplement Manufacturer Audit with Blue Ocean Regulatory today. Whether on-site or remote, we’ll give you the confidence that your products are being made under full compliance with FDA dietary supplement GMPs — and that your brand is protected from costly surprises.