B. Braun Medical, Inc. - March 3, 2015
Issue Date
Mar 03, 2015
Region
Pacific
Category
Drug
$117.00
Contact Name
Russsell A. Gall
Contact Title
Vice President, General Manager Irvine Operations
Address 1
2525 McGaw Ave.
City
Irvine
State
CA
Zip/Postal Code
92614-5841
Country
United States
Inspection Range
Feb 18, 2015 - Mar 03, 2015
Pages
5
First Observation
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning bacteriological contamination and significant chemical, physical, or other change or deterioration in a distributed drug product.
Investigator(s): Rebeca Rodriguez, Brian Ryan, and Sundy Ven