Universal Packaging Systems, Inc. dba PakLab - Dec. 8, 2023
Issue Date
Dec 08, 2023
Region
Pacific
Category
Drug
$117.00
Contact Name
Andrew J. Cheung
Contact Title
Vice President of Corporate Quality and Regulatory Affairs
Address 1
14570 Monte Vista Ave.
City
Chino
State
CA
Zip/Postal Code
91710-5743
Inspection Range
Nov 13, 2023 - Nov 17, 2023
Pages
7
First Observation
Investigations of an unexplained discrepancy and a failure of a batch or any of its components to meet any of its specifications did not
extend to other batches ofthe same drug product and other drug products that may bave been associated with the specific failure or
discrepancy.
Investigator(s): Homero W. Aguilar, Michael T. Cyrus, and Nicholas L. Hunt