Led by the FDA Expert Who Trained FDA Staff on Food Safety Culture
Food science has advanced, and FSMA has been law since 2011. Most U.S. food manufacturers now maintain a Food Safety Plan and designate a Preventive Controls Qualified Individual. Yet major recalls and outbreaks keep happening. What’s missing?
Even the world’s biggest brands continue to face costly recalls and outbreaks year after year:
2025: Mondelēz — Ritz cracker sandwiches recalled after peanut butter varieties were packaged without allergen labeling.
2024: McDonald’s — E. coli outbreak linked to fresh-cut onions served on quarter-pound burgers.
2024: Boar’s Head — 7 million pounds of deli meat recalled after listeriosis cases traced to a processing plant.
2023: Mead Johnson Nutrition — Infant formula recalled for potential contamination with a dangerous microbe.
2022: Abbott Nutrition — Infant formula plant shut down due to potential bacterial contamination.
This webinar reveals why a “check-the-box” food safety plan isn’t enough—and why food safety culture can be the strongest defense against your next crisis.
You’ll learn how to:
1) Define food safety culture in practical terms (and measure it)
2) Spot culture failures that often sit behind technical lapses
3) Strengthen culture across leadership, frontline, and suppliers—before it’s tested
About the Speaker:
Larry Stringer is a nationally recognized food safety expert who spent more than 30 years at the U.S. Food & Drug Administration. He led the development of FDA’s Food Safety Culture training for field and headquarters staff and now serves as an independent contractor with Registrar Corp. This session is the first in a new Registrar Corp series, bringing insider insights from leaders who have shaped the standards our industry follows.
Watch now to learn why plans alone fall short—and how to build a culture that protects consumers and your brand.
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.
