Amneal Pharmaceuticals of New York, LLC - Feb. 7, 2014
Issue Date
Feb 07, 2014
Region
Northeast
Category
Drug
$117.00
Contact Name
David Miller
Contact Title
Senior Vice President, Quality Management
Address 1
85 Adams Ave.
City
Hauppauge
State
NY
Zip/Postal Code
11788
Country
United States
Inspection Range
Jan 09, 2014 - Feb 07, 2014
Pages
3
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): Demitria J. Xiradakis