Lilly del Caribe, Inc. - July 12, 2019
Issue Date
Jul 12, 2019
Region
Southeast
Category
Drug
$117.00
Contact Name
Kevin G. Trivett
Contact Title
Site Head
Address 1
430 Calle Fabril
City
Carolina
State
PR
Zip/Postal Code
00987
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