PETNET Solutions, Inc. - Nov. 3, 2015
Issue Date
Nov 03, 2015
Region
Central
Category
Drug
$117.00
Contact Name
Scott T. Ruzich
Contact Title
Site Manager
Address 1
86-110 Orchard St.
City
Hackensack
State
NJ
Zip/Postal Code
07601
Country
United States
Inspection Range
Nov 02, 2015 - Nov 03, 2015
Pages
1
First Observation
Your executed method transfers ... did not include training of the local staff and an evaluation of the receiving laboratory's capabilities to perform the requisite testing in support of NDA.
Investigator(s): Michael R. Klapal, Liatte Krueger, and Melissa Ray