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Tris Pharma, Inc. - Jan. 23, 2019

Issue Date

Jan 23, 2019

Region

Central

Category

Drug
$117.00

Tris Pharma, Inc.

Contact Name

Ketan Mehta

Contact Title

President and CEO

Form483 Address 1

2033 US Highway 130

Form483 Address 2

Form483 City

Monmouth Junction

Form483 State

NJ

Form483 Postal

08852-3003

Form483 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, Jose O. Hernandez