Caribe Holdings (Cayman) Co., Ltd. dba PuraCap Caribe - July 2, 2021
Issue Date
Jul 02, 2021
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
Jun 15, 2021 - Jul 02, 2021
Pages
11
First Observation
The written stability program does not assure testing of the drug product in the same container-closure system as that in which the drug product is marketed.
Investigator(s): Marian E. Ramirez and Ivis L. Negron Torres