Sunday, March 01, 2009

Form 483s - With surprisingly meaningful advice, is the FDA on a path of self-correction

[Click on Post Title for Link to External Article]

So, the cat's out of the bag. A form-483 is not for your entertainment only. The FDA does want you to pay attention to the 483s if you got them.

I still think it is a little backwards for the FDA to make observations, but not necessarily enforce. The only logical alternative would be that the FDA does not want to penalize you for shortcomings that may be inadvertent and can be overcome voluntarily.

If you receive a 483, here is what the FDA wants you to do (there is some value in repeating somethings straight from the horse's mouth):

1. Not sit on it (okay, that was mine).

2. Assess each of the FDA observations and let the FDA know through a response whether or not you agree with each of them individually.

3. Consider the root causes of all the FDA's observations that you consider as valid.

4. Try corrective action, and if you are able to achieve corrective actions, mention this to the FDA.

5. In cases where corrective action is not promptly forthcoming, send a well-devised action plan to the FDA.

To quote from the article directly: In summary the FDA believes that “a well-reasoned, complete, and timely 483 response is in your best interest”.

And, here is a link to the FDA Presentation on this matter:

Keeping your plant in self-check is probably the first step to avoiding 483s and warning letters. Your "strategy" should not be, "let's wait till something goes wrong". Would you rather have an excellent record or a 'corrected' excellent record?

Yes, perfection is not possible, however, aiming for it most definitely is.

Remember, the FDA itself, in its current state is an organization with veritably very poor standards (peanuts, syringes and Avandias give you any ideas?) on every front.

If you can't even meet the FDA standards for your manufacturing plant, then....

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