Mastering GMP Compliance for Dietary Supplements: A Practical Guide from FSVPServices.com

Selling dietary supplements in the U.S. means more than just high-quality products—it means meeting strict FDA regulatory requirements. Whether you’re a manufacturer, co-packer, private labeler, or foreign supplier, mastering 21 CFR Part 111 (GMP requirements) and completing FDA facility registration are non-negotiable.

At FSVPServices.com, we help supplement businesses worldwide meet U.S. compliance expectations with audit-ready documentation, FDA registration support, and FSVP Qualified Individual services—all in one place.

What Is 21 CFR Part 111?

21 CFR Part 111 is the FDA regulation governing the current Good Manufacturing Practices (cGMPs) for dietary supplements. It applies to all businesses involved in manufacturing, packaging, labeling, or holding dietary supplements intended for U.S. distribution. Key areas include:

• Personnel training and hygiene
• Sanitary facility maintenance
• Equipment cleaning and calibration
• Master manufacturing and batch records
• Quality control review and release
• Product testing and identity verification
• Recordkeeping and traceability

How SOP Templates Simplify Compliance

FSVPServices.com offers a comprehensive SOP Template Package tailored to 21 CFR Part 111, helping you:

✅ Create a structured and audit-ready quality system
✅ Establish consistent operations across all teams
✅ Customize compliant documentation without starting from scratch
✅ Maintain inspection preparedness and regulatory alignment Our templates are ideal for:
- • Supplement manufacturers and co-packers
- • Private label brands managing production through third parties
- • Foreign facilities seeking U.S. market access

FDA Facility Registration: Required for U.S. Market Entry

Under 21 CFR 1.225–1.241, all facilities—U.S. and foreign—that manufacture, process, pack, or hold dietary supplements for the U.S. market must register with the FDA. FSVPServices.com provides:

• FDA Facility Registration Services
• D-U-N-S® Number support
• Biennial renewal management
• U.S. Agent representation for foreign facilities
• Traceability tools aligned with the Bioterrorism Act

Failure to register can result in import refusal, detentions, or enforcement actions.

FSVP Compliance for Foreign Suppliers & U.S. Importers

If you're importing dietary supplements into the U.S., you must comply with the Foreign Supplier Verification Program (FSVP) under FSMA. With FSVPServices.com, U.S. importers and foreign brands get:

• Designated FSVP Qualified Individual (QI)
• Review of supplier GMP documentation (21 CFR 111 compliance)
• Risk-based supplier evaluations
• Maintenance of FSVP records
• Support during FDA inspections and remote record requests

FSVP is not optional—every foreign supplement facility must have a U.S.-based FSVP importer or representative to verify compliance with FDA standards.

Why FSVPServices.com?

With years of experience helping supplement brands enter and grow in the U.S., we combine regulatory precision, documentation tools, and responsive support under one roof. Our solutions include:

• SOP Templates for cGMP compliance (21 CFR 111)
• FDA Facility Registration and Renewal
• U.S. Agent Representation
• FSVP Implementation and Recordkeeping
• Traceability and Recall Preparedness

Whether you’re a U.S. brand owner or an international supplement company expanding into the American market, FSVPServices.com ensures you meet every requirement confidently and completely.

Conclusion

Entering the U.S. dietary supplement market requires more than just product innovation—it demands compliance leadership. With SOP documentation, FDA registration, and FSVP alignment, your business becomes audit-ready and built for sustainable success. Start your compliance journey with confidence. Visit www.FSVPServices.com to explore our GMP and FSVP services or book a free consultation.