Regi US, Inc. - Jan. 15, 2019
Issue Date
Jan 15, 2019
Region
Central
Category
Drug
$117.00
Contact Name
Luis Guzman
Contact Title
Director of Operations
Address 1
8 Fairfield Cres.
City
West Caldwell
State
NJ
Zip/Postal Code
07006-6205
Country
United States
Inspection Range
Dec 20, 2018 - Jan 15, 2019
Pages
1
First Observation
The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in processing, packing and holding.
Investigator(s): Emmanuel J. Ramos