Auro PR, Inc. - May 31, 2023
Issue Date
May 31, 2023
Region
Southeast
Category
Drug
$117.00
Contact Name
Yanira Santos
Contact Title
General Manager
Address 1
Rd. 156 Caguas West Industrial Park, Lot 24
City
Caguas
State
PR
Zip/Postal Code
00725
Inspection Range
May 23, 2023 - May 31, 2023
Pages
4
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): Angelica M. Hernandez, Marian E. Ramirez, and Alan A. Rivera