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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Compliance Check

Compliance Check

Firms:

Fresenius Kabi Austria GmbH
Estermannstrasse 17
A-4010 Linz
Austria
Establishsment Registyration#: F85-28305

Fresenius Kabi Austria GmbH
Hafnerstraees 36
Graz, Austria
FEI #: 3003708554

Fresenius Kabi Norge AS
Svinesundveien 880
NO-1753 Halden
Norway
Establishment Registrstio #: NO 9800250 008
Type V DMF No.: DMF ------

BN070012/0

Summary: Voliven (6% hydroxyethyl starch 130/0.4 in 0/9% sodium chloride injection), a new plasma volume substitute which is indicated for the treatment and prophylaxis of hypovolemia.

There are no ongoing or pending investigations or compliance actions with respect to the above facilities or their product(s). Therefore, the Office of Compliance and Biologics Quality, Division of Case Management does not object to the approval of this supplement.

Marc A. Alston, CSO
CBER/OCBQ/DCM/HFM-624


From:   Stephenson, Franklin
Sent:    Tuesday, November 06, 2007 4:53 PM
To:       CBER Complicheck
Subject:   BN070012/0: Fresenius Kabi:

Hello,

Could you please execute a compliance check on the following manufacturing facility for BN070012/0

Fresenius Kabi Austria GmbH
Estermannstrasse 17
A-4010 Linz
Austria
Establishsment Registyration#: F85-28305

Fresenius Kabi Norge AS
Svinesundveien 880
NO-1753 Halden
Norway
Establishment Registrstio #: NO 9800250 008
Type V DMF No.: DMF ------

Summary:Voliven (6% hydroxyethyl starch 130/0.4 in 0/9% sodium chloride injection), a new plasma volume substitute which is indicated for the treatment and prophylaxis of hypovolemia.

Due Date 21-DEC-2007

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448