IBA Molecular North America, Inc. - Feb. 14, 2014
Issue Date
Feb 14, 2014
Region
Pacific
Category
Drug
$117.00
Contact Name
Mark A. Juarez, Pharm.D.
Contact Title
Facility Manager
Address 1
5900 Suite B Obata Way
City
Gilroy
State
CA
Zip/Postal Code
95020-7065
Country
United States
Inspection Range
Feb 12, 2014 - Feb 14, 2014
Pages
3
First Observation
You did not oversee production operations in a manner to ensure that each PET drug meets the quality and purity characteristics that it is supposed to have.
Investigator(s): Eileen A. Lui and Daniel J. Roberts