FDA is increasing FSVP enforcement—and many importers aren’t prepared for what happens next.
With data-driven targeting and AI-assisted inspections, FDA is identifying high-risk companies faster than ever. The result? More 483 observations, warning letters, import alerts—and compliance failures that become public record.
The problem isn’t just awareness. It’s execution.
In this webinar, we’ll break down what FDA is actually finding during FSVP inspections—and why so many programs fail when it matters most.
You’ll learn:
- The most common FSVP compliance violations
- What happens during an inspection when your program doesn’t hold up
- The real operational gaps behind most FSVP breakdowns (even in experienced teams)
- How to assess whether your program would pass inspection today
- Practical, actionable steps to reduce risk and stay inspection-ready
Whether you’re building your program or trying to strengthen it, this session will give you a clear path to closing common gaps before FDA finds them.
About the Speaker:
Fabiola Negrón is the Director of Food Safety at Registrar Corp. She has been featured in interviews and has written articles for numerous food safety trade publications. Fabiola oversees Registrar Corp’s regulatory specialists that assist domestic and foreign food facilities and U.S. importers with U.S. FDA food safety compliance.
For Medical Device Establishments, who must register?
Owners or operators of establishments involved in producing and distributing medical devices intended for the U.S. market must register annually with FDA and pay an annual registration fee.
What information is submitted for medical device establishment registration?
In addition to registering with FDA, most owners or operators of medical device establishments must also submit a list of all devices during their annual registration renewal.
- U.S. Facilities
- Initial importers must identify the manufacturers of the devices they are importing.
- A device must be listed if they fall under the any of the following:
- Contract Manufacturer
- Contract Sterilizer
- Manufacturer
- Relabeler / Repackager
- Remanufacturer
- Reprocessor of Single Use Device
- Specification Developer
- U. S. manufacturer of export only devices
- Non-U.S. Facilities
- Must list devices, provide a U.S. Agent, and identify importers.
Who must provide medical device listings?
In most cases, all medical device establishments required to register with FDA must also submit a complete list of medical devices manufactured for commercial distribution in the U.S. market.
All facilities that fall under any of the following functions:
- Contract Manufacturer
- Contract Sterilizer
- Foreign Exporter
- Manufacturer
- Relabeler / Repackager
- Remanufacturer
- Reprocessor of Single Use Device
- Specification Developer
- U.S. manufacturer of export only devices
What information is submitted for a medical device listing?
Medical device establishments must list any medical device made in the establishment and the activities the device is meant for.
- Company function (activity)
- Device product code
- Proprietary names
- Importer information
What is a master file?
A Master File is a secure, confidential submission of proprietary product data to a regulatory agency, such as the U.S. Food and Drug Administration (FDA), Health Canada, or the National Medical Products Association (NMPA) in China.
