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Regi US, Inc. - Jan. 15, 2019

Issue Date

Jan 15, 2019

Region

Central

Category

Drug
$117.00

Regi US, Inc.

Contact Name

Luis Guzman

Contact Title

Director of Operations

Form483 Address 1

8 Fairfield Cres

Form483 Address 2

Form483 City

West Caldwell

Form483 State

NJ

Form483 Postal

07006-6205

Form483 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