How to Respond to a US FDA untitled letter - Form 483 or Warning Letter

[Ethan Loh]

Hi everybody,

My company recently had received an untitled letter from US FDA after our inspection.

Can anybody advice how to response to this kind of letter or are there any standard template to follow?

Any help is much appreciated

 

[Al Rosen]

Re: How to response to US FDA untitled letter

Hi everybody,

My company recently had received an untitled letter from US FDA after our inspection.

Can anybody advice how to response to this kind of letter or are there any standard template to follow?

Any help is much appreciated

Try looking at: Responding to a Form 483 or Warning Letter: A Practical Guide

 

[Ethan Loh]

Re: How to response to US FDA untitled letter

Hi AL,

That is really very usefully for me.

Thanks