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Unither Manufacturing, LLC. - May 22, 2019

Issue Date

May 22, 2019

Region

Northeast

Category

Drug
$117.00

Unither Manufacturing, LLC.

Contact Name

Kevin Colangelo

Contact Title

General Manager North America

Form483 Address 1

755 Jefferson Rd.

Form483 Address 2

Form483 City

Rochester

Form483 State

NY

Form483 Postal

14623-3233

Form483 Country

United States

Inspection Range

May 13, 2019 - May 22, 2019

Pages

4

First Observation

There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Investigator(s): Johnna L. Bleem, Niketa Patel