Ferndale Laboratories, Inc. - April 24, 2015
Issue Date
Apr 24, 2015
Region
Central
Category
Drug
$117.00
Contact Name
Christopher J. Stein
Contact Title
Executive Vice President and COO
Address 1
780 W. 8 Mile Rd.
City
Ferndale
State
MI
Zip/Postal Code
48220-2422
Country
United States
Inspection Range
Apr 16, 2015 - Apr 24, 2015
Pages
2
First Observation
There is a failure to thoroughly review 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): Sarah M. Meng and Cheng H. Yen