Get Out of FDA’s Crosshairs – Move to Kansas!

Get Out of FDA’s Crosshairs – Move to Kansas!

March 14th, 2013 // 4:23 am @

March 19, 2013

Want less FDA attention? Consider Kansas.

Our recent Webinar on FDA inspections with Dennis Moore, AUK Technical Services, was quite eye opening. Dennis is one of the few consultants that really focuses on the FDA district office level to see what they are up to in terms of writing 483s and warning letters.

What he has found over the years is that the FDA district offices with the most warning letter activity are:

  • Los Angeles – 14 warning letters in 2008-9
  • New Orleans – 19 warning letters in 2008-9
  • Florida – 15 warning letters in 2008-9

In his interesting Webinar, Moore noted that the FDA is quite aggressive particularly in California. They also often work hand in glove with the California Food and Drug Branch, who also are quite aggressive in poking their noses in what drug companies are doing out there.

So, Moore actually often recommends, depending on what your drug/device/biologic company does, to locate your main offices in a place where there tends to be less FDA scrutiny.

It seems likely, for example, that you are going to get a lot of scrutiny if you are a start up near Irvine, California. About 40% of device companies are in California, and FDA and the CA state FDA likes to come around and see what you are up to quite often.

However, if you can afford to do it in terms of personnel, you might want to consider having your company located in Kansas. Why? Here is a hint:

  • Lenexa, Kansas – 1 warning letter in the last FIVE years

The bottom line is, if you are a class III company based in Kansas, your chances for a big FDA hit are low.

Of course, you can’t ever totally escape FDA, and if the national office gets involved in your case, it does not matter where you are in the US. You’re going to get a lot of attention.

Still, there is no doubt, by locating your main office in a place such as Kansas, you might get a bit less FDA attention.

If you enjoyed that tip, you are in luck! We have rebooked our FDA inspection webinar with Moore on April 11!


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