Paklab - March 17, 2023
Issue Date
Mar 17, 2023
Region
Pacific
Category
Drug
$117.00
Contact Name
Andrew J. Cheung
Contact Title
Vice President of Quality and Regulatory Affairs
Address 1
14570 Monte Vista Ave.
City
Chino
State
CA
Zip/Postal Code
91710-5743
Inspection Range
Mar 13, 2023 - Mar 17, 2023
Pages
7
First Observation
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
Investigator(s): Matthew R. Clabeaux