Getting Ready for FDA

The first thing we recommend that you do is hire or assign an individual who understands the Food Defense rule, HACCP, preventive controls rule, has been through a GFSI audit, and knows who is in your supply chain.


With this knowledge, that individual should be getting you prepared for the next visit by FDA.–2257.aspx


Tattle Tale

Remember that because of FSMA, FDA may make it mandatory for us as auditors to call FDA if we see a non-conformance in your plant.


You may want to voice your concern regarding this with FDA.


Do It Now.

You may want to consider becoming GFSI certified before your current customers ask you to.  For most it’s about a 7-8 month process.


And when you do become certified, it’s a great marketing tool for future prospects.



Are You High Risk or Non High Risk?

Under FSMA, FDA is saying that they are going to be inspecting high risk food companies once every 3 years and non high risk food companies once every 5 years.  One criteria for placing your firm in the high risk category is if you have had past problems like a recall.


So first of all you have to find out what category your company is in.  Our recommendation is not to call them but to find out on your own.


But the frequency of inspections seems curious to me.  If FDA is trying to ramp up this big huge program, it seems strange to me that they are only going to be inspecting some facilities once every 5 years.  Back in the 70’s and 80’s, we knew food processors that were being audited at a minimum of once per year.