Register

Because of FSMA which was passed into law January 2011, any firm that processes, prepares, packs, warehouses or distributes food, must register with the FDA.  To do that go to FDA.gov.

 

Tom

Food Defense

How is your food defense plan coming along?  Is it ready for FDA to look at when they audit your facility?  A food defense plan is part of FSMA.

 

They have initiated this so that you can protect your product from intentional contamination.  Disgruntled employee stuff or a terrorist attack.  They have identified high risk facilities as being bulk liquid receiving and shipping.

 

Tom

FDA Listened!!!!!

FDA listened to your comments.  Congratulations!  Good job!  They changed their thinking apparently on environmental monitoring and finished product testing.  FDA doesn’t know everything.  You all in the food industry have the practical experience.  Keep your comments coming.  You have plenty of time.  YOU can make the law so that YOU can live with it.

 

Tom

SQF Conference

Say hello to either Jane or Jeanette at the SQF Conference in Orlando at the end of this month.  We have a table top exhibit there and at least one of them will be in the exhibit.  Maybe you can talk them out of a drink or coffee.

 

Tom

Training Accountability

We all have training programs.  Some good, some real good and some not so good.  What about continuous training?  If you train a line employee close to their hire date, do you ever give them a refresher?

 

What about accountability?  If you train a line employee on the proper way to wear a hairnet and they don’t abide, are they accountable?  Do they lose pay?  Vacation?

 

Tom

Federal Register

You can make comments on FSMA through the Federal Register.  Those laws can and will impact your business.  A lot of folks are making comments.  If you think there is something unfair in these upcoming regulations, you should tell FDA.

 

Tom

New FDA Stuff

There has been a lot of talk lately about when FDA does get geared up, that they are going to be paying quite a bit of attention to your environmental monitoring programs.  Update these if you haven’t done so in a while.  If you don’t have a program, get one started.  It is not that expensive or time consuming.

 

Our job is to keep you abreast of these updates.

 

Tom

Know Your Supplier …….. Well

In this blog we are recommending that you become better acquainted with your suppliers, especially the major suppliers.  They are a big part of your business.  A meeting twice a year is appropriate.  You should outline goals and objectives.  Get to know them better.  Do not make price and cost the only reason for using a particular supplier.

 

You want that supplier to make money, but also to bring you value every year.

 

Tom

FDA Stepping Up

Recently FDA through the courts issued a permanent injunction on a firm for Listeria innocua.  FDA found Listeria innocua in the facility.  Listeria innocua is considered more of a environmental bacteria, but it may lead to Listeria monocytogenes.

 

It is interesting to note that they issued a permanent injunction here and not a temporary injunction which forced the firm to stop everything (Producing, shipping, receiving ,etc.) until the problem was rectified.

 

A lot different from the old days.

 

Tom

FDA Facts

If you receive a Warning Letter from FDA, do you know what to do?  There are ways to handle it and there are things not to do.  If you do the wrong stuff, you are getting started off on the wrong foot with FDA and then they can really make your life miserable.  The first thing to do is answer the letter within 10 days.

 

Did you know, because of FSMA, FDA can suspend a company’s registration even if they only have reasonable probability that the product in your plant may become contaminated?  They don’t have to find specific examples anymore.

 

Tom