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FSMA Agent Services

FSVP Agent Services for Medical Device & Cosmetic Importers

The Foreign Supplier Verification Program (FSVP) requires U.S. importers of medical devices and cosmetics to verify that their foreign suppliers meet FDA safety and compliance standards. The FDA strictly enforces FSVP regulations, requiring proper documentation, supplier verification, and compliance monitoring

  • Reduces the risk of FDA import detentions and product holds
  • Ensures supplier compliance with FDA regulations
  • Minimizes supply chain disruptions and legal penalties
  • Provides a designated U.S.-based FSVP Agent for regulatory compliance

 

Our FSVP Agent Services provide end-to-end solutions, ensuring full FDA compliance for medical device and cosmetic importers

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Why FSVP Agent Services are Essential for Medical Device & Cosmetic Importers

The FDA requires importers to verify that foreign suppliers comply with U.S. safety standards. Failure to comply can result in:

  • Import refusals and product detentions at U.S. ports
  • FDA warning letters and monetary penalties
  • Loss of import privileges and supply chain disruptions
  • Legal liabilities and increased regulatory scrutiny

Our services help importers comply with FSVP regulations, avoiding delays, ensuring supplier accountability, and maintaining uninterrupted market access

Medical Device FSVP Agent Services

Key Features of Our FSVP Agent Services

Acting as Your Official FSVP Agent

Foreign suppliers of medical devices and cosmetics must designate a U.S.-based FSVP Agent to handle FDA compliance and regulatory communications

  • Handling all FDA inquiries and compliance notifications
  • Ongoing monitoring of FDA regulatory updates
  • Official U.S. FSVP Agent designation for foreign manufacturers

Supplier Verification & Compliance Audits

We conduct risk-based supplier assessments to ensure compliance with FDA regulations for medical devices and cosmetics

  • Supplier risk assessment based on FDA compliance history
  • GMP verification for medical device and cosmetic manufacturers
  • Third-party audit coordination to assess quality and safety standards

Product Documentation & Compliance Review

All US imported medical devices and cosmetics must meet FDA labeling, safety, and regulatory documentation requirements

  • Ingredient safety reviews for cosmetic products
  • Labeling compliance checks to meet FDA requirements
  • Supply chain traceability documentation management

FDA Inspection & Audit Readiness Support

The FDA conducts routine inspections to verify FSVP compliance. We provide pre-inspection preparation and audit support

  • Mock FDA inspections to prepare importers for regulatory reviews
  • Assistance with FDA Form 483 responses and corrective actions
  • Pre-inspection readiness audits to identify compliance gaps

FSVP Record-Keeping & Compliance Documentation

Importers must maintain detailed FSVP records for FDA inspections. We ensure proper record-keeping and compliance

  • Digital storage and management of FSVP documentation
  • Audit-ready compliance reports for FDA reviews
  • Tracking of supplier verification and compliance history

Corrective Action Planning for FDA Detentions

If an imported medical device or cosmetic product is detained by the FDA, we provide rapid resolution services

  • Root cause analysis to identify compliance issues
  • Development of corrective action plans for suppliers
  • Re-submission of documentation to FDA for import clearance

Why Choose Our FSVP Agent Services?

FDA Compliance Expertise

Specialists in FSVP regulations for medical device and cosmetic importers

Full End-to-End Support

Comprehensive supplier verification, document management, and audit preparation

Risk Mitigation Strategies

Proactive compliance solutions to prevent FDA detentions and supply chain disruptions

FSVP Regulatory Monitoring

Ongoing updates on FSVP and FDA requirements to keep your business compliant

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 is an FSVP Agent for medical device and cosmetic importers?

An FSVP Agent is a U.S.-based representative responsible for ensuring FDA compliance, verifying supplier safety standards, and managing FDA communications for foreign manufacturers

Q. Who needs an FSVP Agent for importing medical devices and cosmetics?

Foreign suppliers of medical devices and cosmetic products must appoint a U.S.-based FSVP Agent if they do not have a physical presence in the U.S.

Q. What are the FSVP requirements for importing medical devices?

  • Verification of supplier compliance with FDA regulations
  • Classification of medical devices under FDA guidelines
  • Review of labeling, documentation, and safety records
  • Ongoing monitoring for supplier performance

Q. What happens if an importer fails to comply with FSVP regulations?

  • FDA may refuse entry of non-compliant products
  • Warning letters and financial penalties may be issued
  • Loss of import privileges and supply chain disruptions

Q. How does FSVP apply to cosmetic product imports?

Importers must ensure that cosmetic products comply with:

  • Ingredient safety regulations under the FD&C Act
  • Proper labeling requirements to avoid misbranding
  • Manufacturing compliance with GMP guidelines

Q. How do I appoint an FSVP Agent for my imported products?

You can appoint a qualified U.S.-based FSVP Agent by working with a regulatory compliance expert who specializes in medical device and cosmetic imports

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Our team is friendly, responsive and we love to talk to people interested in what we do. Feel free to get in touch and one of our team will always get back to you. Guaranteed!

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Ensure your medical device and cosmetic imports meet FDA regulations with our expert FSVP Agent services, designed for seamless compliance and hassle-free market access

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