Manufacturer Vetting & FSVP Support for Supplements, NHPs & Foods

Choosing the right manufacturer is one of the most important — and riskiest — decisions a supplement or food brand can make. Your manufacturer controls product quality, regulatory compliance, and ultimately, your brand’s reputation. If they cut corners, you’re the one left holding the liability.

On top of that, if you’re importing dietary supplements, Natural Health Products (NHPs), or foods into the U.S., you must also comply with the Foreign Supplier Verification Program (FSVP) — one of the FDA’s most heavily enforced regulations. FSVP requires importers to verify that foreign manufacturers meet U.S. safety standards. Failure to comply can result in import refusals, warning letters, or products being held at the border.

At Blue Ocean Regulatory, we help supplement and food brands vet manufacturers, qualify suppliers, and build compliant FSVP programs. Whether you’re sourcing from the U.S., Canada, or overseas, we make sure you choose the right partner and meet all FDA requirements for imports.

Why Manufacturer Vetting & FSVP Matter

The supplement industry has thousands of contract manufacturers. Some are world-class, with robust SOPs and third-party certifications. Others operate with minimal controls, offering low prices but high risks.

Common pitfalls include:

  • Manufacturers who say they are “FDA approved” (no such designation exists).

  • Facilities operating without proper cGMP documentation.

  • Overpromising on capabilities they cannot actually execute.

  • Using sub-standard ingredients or skipping required testing.

  • Lack of audit readiness — leaving your brand exposed during FDA inspections.

For importers, the risks multiply. The FDA requires U.S.-based importers to have documented verification of their foreign supplier’s practices. This isn’t a box-checking exercise — FSVP violations are one of the top reasons FDA issues import warnings and detentions.

Without proper vetting and verification, your supply chain can collapse overnight.

What Our Manufacturer Vetting & FSVP Service Covers

We combine regulatory compliance with practical brand-owner experience. Our process ensures you’re working with partners who can deliver safe, compliant, and scalable products.

1. Manufacturer Qualification

  • Review of manufacturer credentials, GMP certifications, and audit history.

  • Assessment of SOPs (testing, change controls, non-conformance handling, record retention).

  • Verification of quality systems against 21 CFR 111 (supplements), 21 CFR 117 (foods), and NNHPD/CFIA standards.

  • Risk-ranking of manufacturers to identify strong, acceptable, and high-risk options.

  • Customized qualification checklist tailored to your product category (capsules, powders, gummies, RTDs).

2. FSVP Compliance

  • Determination of whether your brand qualifies as the importer of record.

  • Review of foreign supplier documentation: hazard analyses, food safety plans, cGMP records.

  • Development of an FSVP plan including hazard identification, supplier verification, and corrective actions.

  • Training for your team to maintain ongoing compliance with FDA expectations.

  • Preparation for FDA inspections and FSVP audits.

3. Ongoing Monitoring & Support

  • Guidance on updating supplier qualification annually.

  • Support for new product launches with additional contract manufacturers.

  • Monitoring of enforcement trends so your brand stays ahead of regulatory changes.

Common Issues We Help Brands Avoid

  • Working with “GMP-certified” manufacturers who only passed a superficial third-party audit.

  • Import refusals because foreign suppliers failed to provide complete hazard analyses or proper testing.

  • Missing allergen control programs and labeling — a common FDA enforcement focus.

  • U.S. brands importing Canadian NHPs without adapting labels and documentation to FDA expectations.

  • Lack of clear roles and responsibilities between brand, importer, and foreign supplier.

Each of these problems can result in lost inventory, enforcement actions, or brand reputation damage — all avoidable with proper vetting and FSVP planning.

Why Brands Choose Blue Ocean Regulatory

We bring a unique perspective: we don’t just know the regulations — we’ve worked hands-on with supplement founders, contract manufacturers, and importers. That means we know how to evaluate not just what looks good on paper, but whether a manufacturer can reliably deliver for your business.

Our team has been featured in NutraIngredients USA, invited to guest speak at events hosted by the Council for Responsible Nutrition, and interviewed on The Nutracast Podcast and other industry platforms. Brands trust us because we translate regulatory requirements into clear, actionable steps that founders and executives can actually implement.

Next Steps

If you’re about to choose a manufacturer, or if you’re already importing products into the U.S., don’t wait until the FDA or a retailer asks questions. Proactive vetting and FSVP compliance protect your supply chain and your brand’s future.

Book a Manufacturer Vetting & FSVP Support Review with Blue Ocean Regulatory today. We’ll help you qualify the right manufacturing partners, build an FDA-ready FSVP program, and give you the confidence that your products are being made and imported the right way.