Elite Laboratories, Inc. - Feb. 2, 2016
Issue Date
Feb 02, 2016
Region
Central
Category
Device
$117.00
Contact Name
Barbara Ellison
Contact Title
Vice President of Quality and Regulatory Affairs
Address 1
165 Ludlow Ave.
City
Northvale
State
NJ
Zip/Postal Code
07647-2305
Country
United States
Inspection Range
Jan 05, 2016 - Feb 02, 2016
Pages
12
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): Jose M. Cayuela, Liatte Krueger, Melissa T. Roy, and Nancy F. Scheraga