Document text
From: Zubkova, Iryna
Sent: Friday, August 13, 2021 5:46 PM
To: DeCiero, Daniel
Cc: Peters, Lori; Zubkova, Iryna; Naik, Ramachandra; Smith, Michael (CBER);
Gottschalk, Laura; Ertel, Donald
Subject: Request for Compliance Check BLA STN 125742/0
Importance: High
Hello Daniel !
Please execute the Compliance Check for BLA 125742/0.
The PD UFA ADD is January 16, 2022. But the internal ADD is August 20, 2021 or August 27, 2021.
Facilities table has been updated and Inspection waiver is attached.
EIR’s will be submitted when they are available.
Thank you,
Iryna
• Applicant Name: BioNTech Manufacturing GmbH
• Product Names: 125742/0 - COVID -19 mRNA Vaccine (COMIRNATY)
• License Number: 2229
• Address: BioNTech Manufacturing GmbH, An der Goldgrube 12 Mainz, , GERMANY
• Application #: 125742/0
• Submission type: BLA
• Projected Approval Date/Action Due Date: August 20, 2021
Summary: For a ctive immunization to prevent COVID -19 caused by SARS -CoV-2 in individuals ≥16 years
of age
List only those manufacturing locations requiring inspection for an original application approval. List all manufacturing locations affected by the change(s) ident ified in a supplement:
Manufacturing/
Testing activities Inspection?
Waiver? Not
Required? Compliance
check
required for
approval? RMS -BLA
entry
required? Comments/
Inspection history
FDA-CBER-2021-5683-1150243
Manufacturing/
Testing activities Inspection?
Waiver? Not
Required? Compliance
check
required for
approval? RMS -BLA
entry
required? Comments/
Inspection history
Manufacturing of
Drug Substance Release and
Sta
bility Testing
Drug Product Release and Stability Testing
Facility : Pfizer Inc.
875 Chesterfield Parkway West
Chesterfield, MO 63017
FEI#: 1940118 Waiver Yes Yes ORA surveillance inspectio n
NAI, 08/19/2019 –
08/20/2019
Manufacture of BNT162b2 drug
substance
Drug Substance Release and Stability Testing (Buildings
Drug Product Release and Stability Testing (Buildings
Facility : Wyeth BioPharma
Division of Wyeth
Pharmaceuticals LLC
a
1 Burtt Road
Andover, MA 01810
FEI#: 1222181 Inspection Yes Yes CBER pre -license
inspection July 19 – 23, 2021
LNP production and bulk drug
product formulation
Fill and finish
Primary packaging
Secondary packaging
Drug Product Release and
Stability testing
Facility: Pharmacia & Upjohn
Company LLCb
7000 Portage Road
Kalamazoo, MI 49001
FEI#: 1810189 Waiver Yes Yes ORA/OBPO
surveillance
inspection VAI, 05/11/2021 –
05/20/2021
LNP production and bulk drug
product formulation
Fill and finish
Primary packaging Inspection Yes Yes BNT162b2 will be
filled in the
building ( area)
and Vaccine Building.
b
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(b) (4)
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(b)
(4)
FDA-CBER-2021-5683-1150244
Manufacturing/
Testing activities Inspection?
Waiver? Not
Required? Compliance
check
required for
approval? RMS -BLA
entry
required? Comments/
Inspection history
Secondary packaging
Drug Product Release and
Stability testing
Facility: Pfizer Manufacturing
Belgium NV
Rijksweg 12
Puurs, 2870 Belgium
FEI#: 1000654629
The syringe line
was previously FDA
inspected but not the
vial filling line.
The Vaccine Building was not previously FDA inspected.
CBER pre -license
inspection
June 24 - July 2, 2021
Drug Product Release and
Stability Testing
Facility: Pfizer Ireland
Pharmaceuticals
Grange Castle Business Park
Clondalkin, Dublin 22
Ireland
FEI#: 3004145594 Waiver Yes Yes ORA/OBPO surveillance inspection
VAI, 11/04/2019 –
11/12/2019
Drug Product Release Testing
(Sterility)
Facility: Hospira Zagreb Ltd.
c
Prudnička cesta 60
10291 Prigorje Brdovečko
Croatia
FEI#: 3010630287 Waiver Yes Yes CDER preapproval inspection
VAI, 11/14/2019 –
11/22/2019
Drug Product Release Testing
(Sterility)
Facility : SGS Lab Simon SA
Vieux Chemin du Poète 10
Wavre, 1301
Belgium
FEI#: 3004186644 Waiver Yes Yes ORA surveillance
inspection
VAI, 09/25/2017 –
09/27/2017
Manufacture, testing and release
(of 2 mL size diluent vials)
Facility: Fresenius -Kabi USA, LLC
Not Require d Yes Yes ORA surveillance inspection VAI,
(b)
(4)
(b)
(4)
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(b) (4)
FDA-CBER-2021-5683-1150245
Manufacturing/
Testing activities Inspection?
Waiver? Not
Required? Compliance
check
required for
approval? RMS -BLA
entry
required? Comments/
Inspection history
FEI#
Manufacture, testing and release
(of 10 mL size diluent vials)
Facility: Hospira, Inc
FEI# Not
Required Yes Yes ORA surveillance
inspection
VAI,
Manufacture, testing and release
(of 10 mL size diluent vials)
Facility: Pfizer Healthcare India Pvt. Ltd.
FEI# Not Required Yes Yes ORA surveillance inspection OAI,
Iryna Zubkova, Ph.D.
Regulatory Project Manager
Center for Biologics Evaluation and Research
Office of Compliance and Biologics Quality
Division of Manufacturing and Product Quality
U.S. Food and Drug Administration
Tel: 240- 402-6755
[email protected]
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1150246