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FSMA Compliance for Dietary Supplements

FSMA Compliance Solutions for Dietary Supplement Importers & Manufacturers

Failure to comply with FSMA regulations can result in import detentions, FDA warning letters, costly recalls, and severe penalties. Our FSMA Compliance Services for Dietary Supplements provide end-to-end solutions, ensuring that your products meet all FDA requirements for safety, quality, and compliance.

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Why FSMA Compliance is Critical for Dietary Supplements

The FSMA shifts the focus from responding to food safety issues to preventing them. Dietary supplement companies must now comply with key FSMA provisions, including:

  • Hazard Analysis and Risk-Based Preventive Controls (HARPC)
  • Foreign Supplier Verification Program (FSVP)
  • Current Good Manufacturing Practices (cGMPs) under 21 CFR Part 111
  • Food Defense Plans for intentional adulteration risks
  • Comprehensive supply chain verification

Non-compliance can lead to:

  • FDA import holds and detentions
  • Product recalls and destruction orders
  • Fines, penalties, and legal liabilities
  • Damage to brand reputation and customer trust

Our FSMA Compliance Services ensure your dietary supplements are FDA-ready, helping you navigate complex regulations and achieve seamless market entry.

FSMA For Dietary Supplement

Our FSMA Compliance Services for Dietary Supplements

FSMA Compliance Gap Assessments

We conduct fully comprehensive audits to identify gaps in FSMA compliance, ensuring your processes, documentation, and controls align with mandatory FDA requirements.

  • Assessment of existing food safety plans and processes
  • Evaluation of HARPC implementation and preventive controls
  • FSVP readiness audits for imported dietary supplements

Hazard Analysis & Risk-Based Preventive Controls Development

Under FSMA, HARPC plans are mandatory for dietary supplement manufacturers. We help develop customized HARPC plans that meet FDA requirements and prevent safety risks.

  • Risk identification and hazard analysis specific to dietary supplements
  • Corrective action procedures to address deviations
  • Ongoing monitoring and verification systems

Foreign Supplier Verification Program (FSVP) Compliance

FSMA requires importers to verify that foreign suppliers comply with U.S. safety standards. We offer FSVP Agent services and full supplier compliance management.

  • Acting as your designated FSVP Agent for FDA compliance
  • Documentation management for supplier safety records
  • Audit support and FDA inspection readiness

cGMP Compliance Support for FSMA Alignment

Current Good Manufacturing Practices (cGMPs) are a core requirement of FSMA. We help ensure cGMP compliance as per 21 CFR Part 111, aligning your manufacturing processes with FSMA regulations.

  • GMP audits of manufacturing, packaging, and distribution facilities
  • Quality control and product testing protocol reviews
  • Corrective action plans to address GMP deficiencies

Supply Chain Program Development & Management

FSMA mandates a robust supply chain program to ensure that dietary supplement ingredients are sourced from verified suppliers. We provide supply chain risk management services to meet these standards.

  • Supplier approval and monitoring programs
  • Ingredient traceability and verification systems
  • Third-party audit coordination for supplier facilities

FSMA Documentation & Record-Keeping Solutions

The Food Safety Modernization Act requires detailed record-keeping to demonstrate full compliance. We provide expert support and documentation management services to ensure you meet FDA standards during inspections.

  • Digital storage of all FSMA-related documentation
  • HARPC and FSVP compliance records management
  • Audit-ready reporting tools for FDA inspections

Why Choose Our FSMA Compliance Services?

Specialized FSMA Expertise

Experts in 21 CFR Part 111 and FSMA regulations specific to dietary supplements.

End-to-End Compliance Solutions

From supplier verification to documentation management and FDA inspection readiness.

Proactive Risk Management

We help you prevent compliance failures with robust preventive control strategies.

Global Compliance Capabilities

International supplier verification for FSVP compliance and global market access.

Global Import Agent have successfully worked with me to land product in the U.S and remain compliant for FDA regulations. I'm really happy with their response times, and easy to use tech platform that facilitates the process.
Jane Mckay
Jane MckayAstute Beverages
I had hit a brick wall trying to get my FDA number for export of my rum to the USA. Ryan and James knew all the right contacts to sort this out for me. I could not have done it without Global Import Agent. They even sorted out my prior notification paperwork for me. I can highly recommend them.
James Singlehurst
James SinglehurstRevival Rum
Ryan, Chris and their team were exceptional in getting our food supplement product FSVP compliant. Pretty good experience with Global Import Agent overall.
Kelvin Yeo
Kelvin YeoAdvagen
Great level of service in the 3 months we have been working with Global Import Agent to date. From the first call with Fabrizzio to the comms with Ryan, James & Carlos, all has been good and the progress we are making is fantastic!
Jeff Webster
Jeff WebsterHunter & Gather
I recently had the pleasure of working with Ryan and his team for a label review of a dietary supplement, which was intended for commercialization in the United States. My experience was overwhelmingly positive, as they provided exceptional and professional support throughout the process.
Renato Di Lorenzi
Renato Di LorenziLoli Pharma
We use Global Import Agent as our FSVP agent for importing dietary supplements into the US from the EU. They've provided us with professional high-quality service thus far. Recommend!
Keiu Kadarik
Keiu KadarikEcosh Life
We were a start up working on our first import, and Global Import Agent was superb in taking care of our documentation and import process. Highly recommend.
Hee Joong Kim
Hee Joong KimMuom Life
Ryan is very helpful from the beginning to end. He responds super fast and he is on point to the issue / objectives.
Wonsik Woo
Wonsik WooLifeLab
James, Ryan and Carlos have been really helpful all along our FSVP. Great service.
Anahi Cabrera Herrera
Anahi Cabrera HerreraScience In Sport
Flexible and helpful FSVP agent. After comparing a couple of agents, this one is the one we picked. No regrets!
Andreas Edström
Andreas EdströmSwedish Signature AB
they are fast, efficient, and always open to help. They have been a great support for me and my company
Alba Rodríguez
Alba RodríguezGricha
Great to deal with, cost efficient and professional, highly recommended
Stephen Goument
Stephen GoumentGolden Turmeric
​What our clients say

Client Feedback

Read what our clients have to say about our services and how we have helped them export product.

Q. What FSMA requirements apply to dietary supplements?

Dietary supplement companies must comply with:

  • Hazard Analysis and Risk-Based Preventive Controls (HARPC)
  • Foreign Supplier Verification Program (FSVP) requirements
  • Current Good Manufacturing Practices (cGMPs) under 21 CFR Part 111
  • Record-keeping and documentation requirements

Q. What is a HARPC plan?

A HARPC plan identifies potential hazards in the manufacturing process and outlines preventive controls to eliminate risks. It includes:

  • Risk assessments for ingredient and process hazards
  • Monitoring procedures for preventive controls
  • Corrective actions for deviations
  • Verification processes for ongoing compliance

Q. What happens if I don’t comply with FSMA regulations?

Non-compliance with FSMA can lead to:

  • FDA import holds and product detentions
  • Warning letters and monetary penalties
  • Product recalls and loss of market access
  • Damage to brand reputation

Q. How does FSVP apply to dietary supplement importers?

FSVP requires importers to ensure that foreign suppliers meet U.S. food safety standards by:

  • Conducting supplier risk assessments
  • Verifying supplier compliance with FDA regulations
  • Maintaining audit-ready documentation

Q. What records must I keep for FSMA compliance?

FSMA requires documentation for:

  • HARPC plans and risk assessments
  • Supplier verification records (FSVP)
  • Product testing results and GMP records
  • Corrective action reports and inspection outcomes

Q. How do I get started with FSMA compliance?

Simply contact us to schedule a consultation. Our experts will provide a customized FSMA compliance plan, tailored to your business needs, ensuring fast, effective, and reliable regulatory success.

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Get FSMA Compliance Support for Dietary Supplements Today

Don’t let FSMA compliance challenges delay your dietary supplement imports or production. Our comprehensive FSMA Compliance Services provide robust solutions for HARPC planning, FSVP management, GMP compliance, and FDA inspection readiness—ensuring regulatory success and uninterrupted market access.

Our friendly team is always happy to help and will reach out as soon as possible.


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