Questions on FDA Registration and 510(k) by an Asian client on a facility move:

QUES 1) The unit which we are delisting, will this be subjected to any USFDA
audit for the production done so far ?

 

ANS:  All production is subject to review / audit by the Agency, usually if there are problems. Once the facility is shut down, such review is only done on the existing records, lot / batch records, logs, validation test reports, etc.  I recommend you do a shut down verification per one of my previous e-mails I just sent you, to verify that everything was operating in specification for the last lot / last item in the last lot produced.

   
QUES 2) The US FDA 510K was first given to the XXXX unit and now is also
available to the YYYY unit. The 510K is very important for us and I am assuming that even if we remove the old unit it will not affect the 510K given to our company.

 

ANS:  The 510(k) remains with the company, unless it's sold with the device. The company's address can change, but that doesn't change the 510(k)'s  ownership.  The FDA however currently has no way to update old 510(k)s on file with them, 'tho they recognize that's a problem.

 

However whenever you change production locations, equipment, processes tied to a 510(k), you are responsible to revalidate the things that changed or moved to prove that the product is still being made the same (and as documented in the 510(k) - see the two guidance documents on changes to devices and the 510(k)') and no quality issues have arisen as a result of the move / changes.

-- jel@jelincoln.com