Tri-Med Laboratories, Inc. - June 21, 2010
Issue Date
Jun 21, 2010
Region
Central
Category
Drug
$117.00
Address 1
68 Veronica Ave.
City
Somerset
State
NJ
Zip/Postal Code
08873-3464
Country
US
Inspection Range
May 18, 2010 - Jun 21, 2010
Pages
5
First Observation
Drug products failing to meet established specifications are not rejected.
Even though this observation was previously cited, on 9/25/2009, no further action was taken by the Quality Unit regarding the following 23 finished product lots which were manufactured using failing components.
Investigator(s): Atul J. Agrawal, Karen D'Orazio, Jessica M. Monteiro, and Nicholas A. Violand