Don’t Put Your Pharma Company in LA?
March 12th, 2013 // 3:40 pm @ jmpickett
March 14, 2013
The $50,000 FDA Compliance Mistake!
One of the most interesting pieces of pharmaceutical-related information we have seen recently is how differently the various FDA district offices behave. There is no doubt about it: Some FDA district offices are more strict than others.
For example, in 2011, the LA district office issued 14 warning letters, and the New Orleans district office issued 19. Cincinnati also was quite active with 18 warning letters issued, and so was Florida with 15 warning letters issued.
On the other hand, there were a few district offices that issued very few warning letters. The office in Philadelphia issued only 2, and the office in Lenexa, Kansas issued only 1!
What does this tell us? Well, it indicates obviously that FDA activity in the warning letter department is often dependent upon what area of the country you live in.
It also tells us that if you are interested in having possibly less interaction with FDA, there are certain areas of the country you should consider, and other parts of the country you might want to think twice about. If you locate your operations in, say, Los Angeles, you are probably more likely to run into a subject matter expert FDA auditor. On the other hand, if you get an inspection in Michigan or Kansas, you are probably more likely to run into an inspector with not as much expertise in many pharmaceutical-related fields and specialties.
Of course, any pharmaceutical organization can be inspected or given a warning letter at any time. And if the national FDA office gets involved in your case, all bets are off. But, for many routine FDA inspection matters, one can make a strong argument that locating your headquarters in say, Kansas, might be a wiser choice than New Orleans.
You may find that you can only recruit the talent that you need for certain parts of your business in LA, for example. What you can do is locate the essential employees and that part of the company in LA, and have your headquarters in a place where FDA tends to be more lenient.
Interesting, isn’t it? Actually, I pulled this idea from a recent Webinar of ours, and it so happens that we will rerun that event on March 28…:). Check it out!
