Compliance Check Email - Wilate, November 17, 2009

From:                     CBER Complicheck

Sent:                      Tuesday, November 17, 2009 10:57 AM

To:                         Michaelis, Marion; CBER Complicheck

Subject:                 RE: Compliance Check - STN 125251/0 Octapharma- Coagulation Factor VIII/von Willebrand Factor Complex (Human)

Firms:

Octapharma Pharmazeutika Produktionsges.m.b.H.

Oberlaaer Strasse 235

Vienna, Austria A-110

FEI # 3002809097

U.S. License # 1646

STN #: 125251/0

Summary: BLA for von Willebrand Factor Concentrate (Human) [Wilate] manufactured at their Vienna, Austria location.  Wilate is used for treatment ------(b)(4)----- for von Willebrand disease

An inspection of Octapharma Pharmazeutika Produktionsges.m.b.H., located at Oberlaaer Strasse 235, Vienna, Austria A-110 (FEI # 3002809097), was conducted July 22-31, 2008 and classified as -----------------------------------------(b)(5)------------------------------------------------- as Voluntary Action Indicated (VAI).  An inspection waiver memo is dated August 17, 2009.  Therefore, the Office of Compliance and Biologics Quality, Division of Case Management does not object to the approval of this supplement.

Kimberly A. Cressotti, CSO

CBER/OCBQ/DCM/HFM-624

_____________________________________________

From:                     Michaelis, Marion 

Sent:                      Tuesday, November 10, 2009 8:30 AM

To:                          CBER Complicheck

Subject:                Compliance Check - STN 125251/0 Octapharma- Coagulation Factor VIII/von Willebrand Factor Complex (Human)

Need Compliance Check For The Below Mentioned Firm:

The inspection for this file was waived and below is the memo (also in EDR) with concurrence noting this

 

 << File: 125251-0-InspWv-8-7-09 (2).pdf >>

 

Firm:

Octapharma Pharmazeutika Produktionsges m.b.H.

Oberlaaer Strasse 235  A-1100

Vienna, Austria

 

LIC#:

1646

 

FEI#:

3002809097

 

STN:

125251/0

 

Short Summary From RMS BLA:

BLA for von Willebrand Factor Concentrate (Human) [Wilate] manufactured at their Vienna, Austria location.  Wilate is used for treatment ------(b)(4)----- for von Willebrand disease