FDA won't take any action as long as you can show effort

[antho10359]

Do I have your attention?

FDA will not take any action as long as the company can demonstrate it is making an effort to comply with the regulations.

Just wanted to throw that statement out there for reaction and discussion.

 

[Aaron Lupo]

Do I have your attention?

FDA will not take any action as long as the company can demonstrate it is making an effort to comply with the regulations.

Just wanted to throw that statement out there for reaction and discussion.

That all depends on how your FDA Inspector interprets things. Just showing an effort does not mean you will not receive a 483 for not complying with the regulations.

 

[Wes Bucey]

Whence the source of these "urban myths" (no FDA action if effort is shown or if hardship for company?)

To my knowledge, the FDA is playing hardball, NOT softball, when it comes to speed and severity of enforcement activity. The one thing absolutely certain is that FDA will NOT accept "anecdotal" evidence of compliance. If an organization doesn't document compliance, it has a tough row to hoe to avoid penalties (and also note the penalties are becoming more severe.)

When the FDA "slips up" on enforcement, it comes back with a vengeance when the slipup is discovered.

Quite frankly, I think companies frequently shoot themselves in the foot when it comes to dealing with FDA regulation. In my mind, they deserve penalties, up to and including imprisonment for top officers, when they spend time looking for ways "around" FDA regulations instead of seeking efficient ways to comply with FDA regulations. If the regulations are useless, the companies need to lobby to have them deleted or modified (with full public participation and disclosure in the process.)

No one puts a gun to the heads of organizations subject to FDA regulation, forcing them to make products or provide services. However, when those executives choose to make those products or provide those services, they should be willing to abide by the regulations.

 

[Al Rosen]

Do I have your attention?

FDA will not take any action as long as the company can demonstrate it is making an effort to comply with the regulations.

Just wanted to throw that statement out there for reaction and discussion.

Where did you get this idea? Take a look at (broken link removed)
and
(broken link removed)

 

[antho10359]

I have worked in quality for several companies over the last 20 years. At some point in each company, someone has cited one or both of the matras regarding "no FDA action if we can show we are trying" and "FDA won't force compliance if undue hardship"

I think the later may have its roots in some of the guidance documents I have seen regarding FDA's position on validation and documentation stating that the company should take the "least burdensome approach." This has been used by some to paint with a wider brush.

I was just wondering if anyone else had run into this philosophy. (by the way... I don't buy into either)

 

[Wes Bucey]

I have worked in quality for several companies over the last 20 years. At some point in each company, someone has cited one or both of the matras regarding "no FDA action if we can show we are trying" and "FDA won't force compliance if undue hardship"

I think the later may have its roots in some of the guidance documents I have seen regarding FDA's position on validation and documentation stating that the company should take the "least burdensome approach." This has been used by some to paint with a wider brush.

I was just wondering if anyone else had run into this philosophy. (by the way... I don't buy into either)

As Al Rosen will probably echo,
"Don't ever let a false assumption go unchallenged!"

It is detrimental to organization and your own career.
Al and I were both quick to point out the error of the statements, as should anyone who hears them in meaningful or casual conversation.

 

[Jen Kirley]

I felt like what I was reading was an extrapolation of what may actually be true. Stretching the facts.

I can say from my experience that regulating agencies, such as OSHA, may assist in bringing compliance through cooperation, and very small companies may be exempt from some requirements because they don't have enough resources. Further, if the company can show they are making reasonable effort to comply, fines or other consequences may be less burdensome than signs of willful ignorance or persistent negligence.

However, the assertion "FDA will not take any action as long as the company can demonstrate it is making an effort to comply with the regulations" doesn't pass what I'll call the Straight Face Test.