Document text
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742 .0
Response to 16Aug 2021 FDA IR–STN 125742.0 IR RE Diluent Suppliers
PFIZER CONFIDENTIAL
Page 1The review team has the below information request for y ou regarding y our diluent suppliers .
QUERY 1
Due to the Warning Letter (reference WL 320 -20-31 issued 03/25/2020) and Official Action
Indicated status of Pfizer Healthcare India Pvt. L td. (FEI# 3008316085), the Agency will not
approve the diluent supplied from that manufacturer as part of your BLA. Please
acknowledge this notification and remove all references to this supplier fro m the BLA,
including in the recentl y added Diluent Manufacturers table .
RESPONSE 1
Pfizer acknowledges confirmation of this request and Pfizer Healthcare India Pvt. L tdis
removed from the Diluent Manufacturers table. The Diluent Manufacturers table in
Section3.2.P.3.1 Manufacturer(s) (DILUENT), has been updated.
An updated Form 356H is also provided.
Also, the table containing the supplier of the 10 mL vialhas been updated by deleting the
10mL Vial supplier to Pfizer Healthcare India Pvt. L td. Table 1 as amended with the updated
container closure supplier information is shown below for reference .
Table 1.0.9% Sodium Chloride Injectio n Container/Closure Information 10 mL vial
Primary Packaging
ComponentDirect Solution
Contact (Yes/No)Description Manufacturer Name and
Address
Container Yes Plastic Vial, 10 mL
Closure Yes Stopper, 20 mm Gray
Compound, Snap Plug
090177e197d56f81\Approved\Approved On: 17-Aug-2021 18:58 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149874
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742 .0
Response to 16Aug 2021 FDA IR–STN 125742.0 IR RE Diluent Suppliers
PFIZER CONFIDENTIAL
Page 2Table 1.0.9% Sodium Chloride Injectio n Container/Closure Information 10 mL vial
Primary Packaging
ComponentDirect Solution
Contact (Yes/No)Description Manufacturer Name and
Address
SealaNo Seal, 20 mm, Flip -Off,
Green, Matte Top
a.While integral to the drug product packaging, the aluminum seal is not considered a primary packaging
component, as it does not have direct contact w ith the solution. The seal keeps the ela stomeric closure in its proper
position in the neck of the vial. It does not have solution contact.
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
Section 3.2.P.3.1 Manufacturer (s) (DILUENT ),replaced
Previously submitted supporting documentation
None
090177e197d56f81\Approved\Approved On: 17-Aug-2021 18:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149875