FDA notification of address change

J

Jane1

Registered
#1
#1
Hi everyone,

I have a bit of an odd question - my company is going to change its office location. this is solely the office where only administrative work was done, not related to manufacturing at all.
the office is registered in the FDA and so I wish to update the facility information with the new address.

my question is this - do you think that the address change on the FDA website might trigger an audit?
did it happen to anyone in the past?

thank you!! :)
 
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Watchcat

Watchcat

Trusted Information Resource
#3
#3
I don't do registration or listing, but I'm wondering which address you are planning to change. You don't actually register companies, but "establishments" that are engaged in one or more activities that FDA has identified as requiring registration:

Who Must Register, List and Pay the Fee

Another question is where is the office now? Is it at the same location as the manufacturing facility? If not, why was it registered previously? That is to say, in which of these activities was it engaged that required its registration in the first place?

I have to say that, 7382.845 notwithstanding, I would expect a change in a location that has a direct impact on production quality (eg., manufacturing, sterilizing) to catch FDA's attention, not sharply or immediately, but duly noted, because things can go wrong when you move a complex activity from one location to another. And I expect FDA has seen them go wrong before.

I would not expect a change in strictly administrative offices to interest it much, although if "administrative work" includes running the company (HQ) I would want FDA to have the address for critical correspondence. Since I don't do registration & listing, I don't know what your options are here. If you can list both a street and mailing address for the manufacturing facility, and any mail FDA sent to the mailing address would get to the appropriate person, then you would have that covered.
 
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