Les Emballages Facoteck, Inc. - Dec. 1, 2017
Issue Date
Dec 01, 2017
Region
HQ
Category
Drug
$117.00
Contact Name
Benoit Fortin
Contact Title
Directeur General
Address 1
35 Ch Victoria W Bureau 236
City
Scotstown
State
QC
Zip/Postal Code
J0B 3B0
Country
Canada
Inspection Range
Nov 27, 2017 - Dec 01, 2017
Pages
6
First Observation
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Investigator(s): Rajiv R. Srivastava