Kirkman Laboratories, Inc. - Aug. 6, 2013
Issue Date
Aug 06, 2013
Region
Pacific
Category
Drug
$117.00
Contact Name
Lawrence A. Newman
Contact Title
Chief Operating Officer Technical & Regulatory Affairs
Address 1
6400 Rosewood St.
City
Lake Oswego
State
OR
Zip/Postal Code
97035-5392
Country
United States
Inspection Range
Jul 15, 2013 - Aug 06, 2013
Pages
8
First Observation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Investigator(s): Marijo B. Kambere and Marie P. Kelly-Doggett