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From: Jones, Kathleen (CBER) <[email protected]>
Sent: Monday, August 30, 2021 5:26 PM
To: Smith, Michael (CBER) <[email protected]>; Peters, Lori <[email protected]>;
Fontan, Laura <[email protected]>; Price, Gregory <[email protected]>; Lynch,
Christian <[email protected]>; Emerson, Debra <[email protected]>; Eltermann, John <[email protected]>; Renshaw, Carolyn <[email protected]>; Allen,
Ekaterina <[email protected]>
Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura
<[email protected] v>; Sutkowski, Elizabeth M. <[email protected]>
Subject: RE: STN 125742.0.60: revised 483 responses for the Andover site
Mike,
This is not mentioned in the combined memo. It is covered in the 483 response memo. There is no
need for additional follow -up with Pfizer, their response was acceptable. Thank you and have a good
day.
Kathy
From: Smith, Michael (CBER) < [email protected] >
Sent: Monday, August 30, 2021 3:25 PM
To: Peters, Lori < [email protected] >; Jones, Kathleen (CBER) <[email protected] >;
Fontan, Laura < [email protected] >; Price, Gregory <[email protected] >; Lynch,
Christian < [email protected] >; Emerson, Debra <[email protected] >; Eltermann,
John < [email protected] >; Renshaw, Carolyn < [email protected] >; Allen,
Ekaterina < [email protected] >
Cc: Naik, Ramachandra < [email protected] >; Gottschalk, Laura
<[email protected] >; Sutkowski, Elizabeth M. < [email protected] >
Subject: STN 125742.0.60: revised 483 responses for the Andover site
Lori and the DMPQ team,
Pfizer submitted amendment 60 on August 18th containing updated responses to
the FDA form 483 that was issued to the Andover site in response to the August 17
th t-con that we had w/ them, but I don’t see that mentioned in your combined
review. Can you please respond to my e -mail indicating that you reviewed
amendment 60 and found their response to be acceptable?
Mike
FDA-CBER-2021-5683-1150382