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Lilly del Caribe, Inc. - July 12, 2019

Issue Date

Jul 12, 2019

Region

Southeast

Category

Drug
$117.00

Lilly del Caribe, Inc.

Contact Name

Kevin G. Trivett

Contact Title

Site Head

Form483 Address 1

430 Calle Fabril

Form483 Address 2

Form483 City

Carolina

Form483 State

PR

Form483 Postal

00987

Form483 Country

United States

Inspection Range

Jul 09, 2019 - Jul 12, 2019

Pages

3

First Observation

You have implemented an inadequate NIR model maintenance and validation strategy for the manufacturing platform.
Investigator(s): Marian E. Ramirez