Caribe Holdings (Cayman) Co., Ltd. dba PuraCap Caribe - March 10, 2020
Issue Date
Mar 10, 2020
Region
Southeast
Category
Drug
$117.00
Contact Name
David Fuster
Contact Title
Plant Manager
Address 1
State Rd. 698, Km. 0.8 Barrio Mameyal
City
Dorado
State
PR
Zip/Postal Code
00646
Country
United States
Inspection Range
Mar 03, 2020 - Mar 10, 2020
Pages
11
First Observation
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of inprocess material and the drug product.
Investigator(s): Jennifer A. Quinones, Marian E. Ramirez, Ivis L. Negron Torres, and Jose Velez