Kirkman Laboratories, Inc. - June 24, 2015
Issue Date
Jun 24, 2015
Region
Pacific
Category
Drug
$117.00
Contact Name
Lawrence A. Newman
Contact Title
Chief Operational Officer Technical & Regulatory Affairs
Address 1
17305 63rd Ave.
City
Lake Oswego
State
OR
Zip/Postal Code
97035-5392
Country
United States
Inspection Range
Jun 03, 2015 - Jun 24, 2015
Pages
4
First Observation
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Investigator(s): Nancy E. Byerly