jueves, 7 de febrero de 2013

ERRATA: http://elbiruniblogspotcom.blogspot.com.ar/2013/02/warning-letters-and-notice-of-violation.html


Please note that your story about FDA warning letters and it’s reference to Quintiles is INCORRECT:
The warning letter referenced was not issued to Quintiles, but rather to Swedish Orphan Biovitrum AB (aka SOBI). SOBI is a Swedish company, and the FDA requires a US agent be identified to represent them to FDA and likewise receive correspondence from FDA.
In accordance to FDA regulations, Quintiles serves as the US agent for Swedish Orphan Biovitrum AB.
The warning letter was not issued to Quintiles nor was it related to services provided by Quintiles.
Quintiles served as the US mailbox for this foreign company and will likewise delivered the response to FDA as prepared by Swedish Orphan Biovitrum AB (SOBI).
As identified in the header, this letter was directed to Swedish Orphan Biovitrum AB, not to Quintiles. Swedish Orphan Biovitrum AB
Attn: Toni Marie Nearing
Global Regulatory Affairs Quintiles, Inc.
[U.S. Agent for Swedish Orphan Biovitrum AB]
1801 Rockville Pike, Suite 300
Rockville, MD 20852
*** Please remove any reference to Quintiles as having received an FDA warning letter. To say or suggest that we have is patently false.
Phil Bridges
Director, Corporate Communication
Navigating the new health
P.O. Box 13979
Research Triangle Park, NC 27709
4820 Emperor Boulevard
Durham, NC 27703
Office: + 1 919 998 1653
Mobile: + 1 919 457 6347
Fax: + 1 919 518 9077

No hay comentarios:

Publicar un comentario