Kath Khemicals, LLC - Dec. 18, 2017
Issue Date
Dec 18, 2017
Region
Central
Category
Drug
$117.00
Contact Name
Zachary T. Holston
Contact Title
CEO
Address 1
6050 19 Mile Rd.
City
Sterling Heights
State
MI
Zip/Postal Code
48314-2101
Country
United States
Inspection Range
Dec 11, 2017 - Dec 14, 2017
Pages
5
First Observation
Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
Investigator(s): Bei Y. He