How is the role of FDA Changing?

Senate bill S. 510: FDA Food Safety Modernization seeks enhanced ability for the FDA to: Access basic food safety records at facilities – Review Performance Data.

If the FDA is asking for this authority then, this implies that they currently do not have the authority to do so.

I know this sounds a bit old school but back in the days when I was a Plant QA Manager (You’ll have to guess how many years ago that was) We were inspected by he FDA at least twice e year and I vividly remember on more than once standing in doorway to our lab not allowing access to the FDA inspector. Stating that it was our company policy not to give Access to testing data. That if the inspector wanted access they would have to request that in writing to our corporate offices. It always worked and the FDA inspector would back off.

So what has changed that now allows the FDA to show up and take samples (Swabs) to find a specific microbe?  How does that differ from gaining access to food safety records?  The only difference I see is who took the sample.

Why does this matter?  Well let’s look at the impact. I received a panic call from a client stating the FDA was on site taking over 1800 swabs including fork truck tires because his company is one of many suppliers to a company that is recline their product due to e-coli.  He was asking what should he do??

Look at, Plainview Milk Products Cooperative, Plainview, Minn. recall of instant nonfat dried milk, whey protein, fruit stabilizers, and gums.

I’m curious at what your thoughts are. Please leave your comment below.

-Steve Gruler

2 thoughts on “How is the role of FDA Changing?

  1. Jim

    FDA is just using the work “smarter” not harder mentality. However, they seem to be focused on the “local” issue and not the true bigger picture or implication of their actions.

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