FSMA Enforcement Delay Stirs Controversy

When federal regulators ask for comments to proposed rule changes, it’s a lot like a game of Marco Polo – with 300 million swimmers. Commenters either drown the agency with a flood of conflicting opinions or they barely cause a ripple.

A Look Inside TraceGains Network

Marc Simony, Vice President of TraceGains Network, shared some valuable insights into not only what TraceGains Network is, but, more importantly, what value TraceGains Network provides to both TraceGains customers and suppliers.  

American Baker's Association (ABA) Convened in Denver, CO to Discuss Key Issues

More than 60 members of the American Baker’s Association (ABA) gathered in Denver this week for the summer Federal Technical and Regulatory Affairs Committee (FTRAC) meeting.

Preventive Controls Qualified Individual: One Size Does Not Fit All Food Manufacturers

The FDA’s Preventive Controls for Human Food regulation was published on September 17, 2015. It applies to facilities required to register with FDA under section 415 of the Food, Drug, & Cosmetic Act, and these facilities must comply if they...

Are Consumers Responsible for Driving FSMA’s FSVP?

In a roundabout way, yes. In the globalized food industry where complex supply chains are common, the Foreign Supplier Verification Program (FSVP) seems to have been introduced at an appropriate time for Americans.

The Trump Administration or Whistleblowers: Which Might Have More Impact on FSMA Compliance?

For small businesses, defined by the FDA as a business that employs fewer than 500 persons, there are fewer than 200 days left to become compliant with FSMA’s Preventive Controls for Human/Animal Food rules (the actual compliance deadline is...

FSMA and the New Congress: What’s Likely and Unlikely to Happen

With this post, we’d like to say that we're not trying to make a political statement for or against anyone. We're simply trying to assess the new dynamics unfolding in Washington and how that might affect the companies we serve. We consistently...

Practical Compliance Tips for FSMA from Top Food and Beverage Companies

While the Food Safety Modernization Act (FSMA) rules have all been finalized for quite a few months now, there are still significant amounts of confusion and questions regarding implementation and what companies actually need to do from a food...

FDA Inspections: Rights and Reasonableness

When it comes to FDA inspections, it’s rules, and the new rules for the Food Safety Modernization Act's (FSMA) inspections, what are the core rights and responsibilities of your facility?

Supply Chain Transparency and FSMA

With the finalization of all rules that make up the Food Safety Modernization Act (FSMA) and compliance dates already in effect for the Preventive Controls rules for large companies, one common denominator stands out amongst them all: the...

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