
Information Request Email, Facility Operations, January 15, 2015 - BEXSERO


 
 
RECORD OF TELEPHONE CONVERSATION

Submission Type: BLA     Submission ID: 125546/0     Office: OVRR

Product:
 Meningococcal Group B Vaccine

Applicant:
 Novartis Vaccines and Diagnostics, Inc.

Telecon Date/Time: 14-Jan-2015 02:50 PM     Initiated by FDA? Yes

Telephone Number:

Communication Categorie(s): 
 1. Information Request

Author: DON ERTEL

Telecon Summary: 
 IR Regarding operations at the -(b)(4)- Facility.

FDA Participants: KIRK PRUTZMAN, DON ERTEL, ED WOLFGANG, RAMACHANDRA NAIK

Non-FDA Participants: PATRICIA STOEHR

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:


From: Ertel, Donald 
 Sent: Wednesday, January 14, 2015 2:50 PM
 To: Stoehr, Patricia (patricia.stoehr@novartis.com)
 Cc: Naik, Ramachandra; Prutzman, Kirk C; Wolfgang, Edward
 Subject: Novartis Vaccines and Diagnostics -(b)(4)-, Italy Facility

Dr. Stoehr,

Question(s) related to operations at Novartis Vaccines and Diagnostics 
------------------------(b)(4)----------------------- 
 ---------(b)(4)---------
•Are there any U.S. approved (commercial, not clinical) products being manufactured (produced) at the (b)(4) Facility?
•If not, when was the last date of manufacture of an U.S. approved product?
•If so, which products are being produced?

Please respond via email.

Best Regards,

Donald Ertel MT(ASCP),CQA(ASQ) 
 Lieutenant Commander/ Regulatory Officer 
 US Public Health Service FDA/CBER/OCBQ/DMPQ
 FDA Headquarters
 10903 New Hampshire Avenue
 Silver Spring, MD 20993
 Building 71, Room 6029
 Office Phone: 240-402-9511
 Fax: 301-595-1306
 Donald.ertel@fda.hhs.gov
