REJIMUS Monthly Newsletter – April 2023
Why Should You Close Out a Form 483 Observation Notice or Warning Letter?
We’ve heard over the years frequent enough advice given by some other GMP/FDA consultants (and even some lawyers) to companies in the food and supplement sectors, to not petition to close out a Form 483 or Warning Letter, should one get issued. Think about that for a minute!

REJIMUS Monthly Newsletter – March 2023
That’s One Hell of A Food Safety Plan!
So should you have a Food Safety Plan? Well, of course, it depends. It most instances, yes, but within that consideration, what should be included? Again, it depends. Not all FSP’s are or should be created equal. We figured it would be good to recap what those critical aspects are of a food safety plan to be included.

REJIMUS Monthly Newsletter – February 2023
Bad Boys, Bad Boys, what you gonna do? What you gonna do when FDA comes for you?
This year brings renewed speculation about the largely anticipated news of the FDA fiiiiinally enforcing NDI Notifications. While the NDI draft guidance is still making its way through the rule making process, the FDA is on record that they’ve been hunting and have found numerous potential violators.

REJIMUS Monthly Newsletter – January 2023
How’s Your 2023 Compliance Strategy Looking?
First off, personally we hope big things are slated for you this year, but most importantly, good health! Without that, nothing else truly matters. Second to that, what are your regulatory initiatives for the year? Is there a build-out or acquisition of a new ingredient or food production facility in the cards? How about just a new product launch?

REJIMUS Monthly Newsletter – October 2022
FDA To Update Definition of ‘Healthy’ Claims
In the world of ever-evolving regulations, the latest major notation is the adjustment to the definition of “healthy” just proposed by FDA. The foundation of this concerns the application of “implied” Nutrient Content Claims. This opens the door to interpretation, and therein lies the challenge, as many of us have had or continue to have to deal with.

REJIMUS Monthly Newsletter – September 2022
You down with F.S.V.P.? Yeah you know me!
The FDA is still at it, of course, and given the high visibility of recent Warning Letters to food and supplement companies not having their Foreign Supplier Verification Program (FSVP) tight for review upon request from the Agency, this is a strong indication of what will certainly come next with respect to follow-on actions, if not resolved properly.

REJIMUS Monthly Newsletter – August 2022
More successful first time Notifications…
So what are the secrets to first time successful GRAS and NDI Notifications? For starters, it is the people and their work ethic! I’m proud of the team we have built and more is coming. Next, it is having exceptional project organization and management, access to raw data and compliance documentation, not just numbers on a report or CoA.

REJIMUS Monthly Newsletter – July 2022
You down with F.S.V.P.? Yeah you know me!
The FDA is still at it, of course, and given the high visibility of recent Warning Letters to food and supplement companies not having their Foreign Supplier Verification Program (FSVP) tight for review upon request from the Agency, this is a strong indication of what will certainly come next with respect to follow-on actions, if not resolved properly.