Kirkman Laboratories, Inc. - April 14, 2017
Issue Date
Apr 14, 2017
Region
Pacific
Category
Drug
$117.00
Contact Name
Lawrence A. Newman
Contact Title
COO
Address 1
17387 63rd Ave.
City
Lake Oswego
State
OR
Zip/Postal Code
97035
Country
United States
Inspection Range
Mar 29, 2017 - Apr 14, 2017
Pages
10
First Observation
Control procedures are not established which 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): Tracy K. Li