


Facility Inspection Waiver, January 12, 2012 - Hyqvia

 
From: Shields, Mark
Sent: Tuesday, January 10, 2012 11:44 AM
To: 'Blackshere, Angela L'
Cc: Maruya, Aiko
Subject: RE: 125402/0 - Facility Inspection Question re: Baxter Immune Globulin 
Infusion (Human), 10% with Recombinant Human Hyaluronidase

Hi Angela,

I have been informed that (at this point) FDA plans to waive the facility 
inspection.

Best Regards,
Mark A. Shields, RAC
Regulatory Project Manager
HFM-380  FDA/CBER
Office of Blood Research and Review
Division of Blood Applications
301-827-6173 fax 301-827-2405
email: mark.shields@fda.hhs.gov
1401 Rockville Pike
Rockville, MD 20852-1448

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From: Blackshere, Angela L [mailto:Angela_Blackshere@baxter.com] 
Sent: Friday, January 06, 2012 12:04 PM
To: Shields, Mark
Cc: Maruya, Aiko
Subject: RE: 125402/0 - Facility Inspection Question re: Baxter Immune Globulin 
Infusion (Human), 10% with Recombinant Human Hyaluronidase

 

Dear Mark:

Do you have a response to my below question?  It would be greatly appreciated if 
a response can be provided next week.

Best regards and happy new year,

Angela

*************************************

Angela Blackshere
Sr. Director, Global Regulatory Affairs
Baxter Healthcare Corporation, Baxter BioScience
One Baxter Way
Westlake Village, CA 91362
(805) 372-3050/Phone
(805) 372-3052/Fax
angela_blackshere@baxter.com

From: Blackshere, Angela L 
Sent: Wednesday, December 21, 2011 12:23 PM
To: Shields, Mark
Cc: Maruya, Aiko
Subject: RE: 125402/0 - Facility Inspection Question re: Baxter Immune Globulin 
Infusion (Human), 10% with Recombinant Human Hyaluronidase

Dear Mark:

On another note, I would like to follow-up with you regarding FDA’s facility 
inspection plans, if any.  Baxter is ending the year and making plans for 
manufacture of rHuPH20 in 2012 and are aware that FDA likes to see manufacture 
of product during inspections.  Do you know when FDA will make a decision 
regarding inspection plans, so we can schedule manufacture of rHuPH20 lots 
accordingly?

Best regards,

Angela

*************************************

Angela Blackshere
Sr. Director, Global Regulatory Affairs
Baxter Healthcare Corporation, Baxter BioScience
One Baxter Way
Westlake Village, CA 91362
(805) 372-3050/Phone
(805) 372-3052/Fax
angela_blackshere@baxter.com

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