Tris Pharma, Inc. - Jan. 23, 2019
Issue Date
Jan 23, 2019
Region
Central
Category
Drug
$117.00
Contact Name
Ketan Mehta
Contact Title
President and CEO
Address 1
2033 US Highway 130
City
Monmouth Junction
State
NJ
Zip/Postal Code
08852-3003
Country
United States
Inspection Range
Jan 09, 2019 - Jan 23, 2019
Pages
4
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): Tamil Arasu, Russell Glapion, and Jose O. Hernandez