FDA 483 - Universal Packaging Systems, Inc. dba PakLab - March 17, 2023

Paklab, a contract manufacturer in Chino, CA, was cited with five observations during an FDA inspection. The firm failed to establish adequate procedures for water system and cleaning validations, lacked specific identification tests for components, and maintained unsanitary building conditions. Additionally, issues were noted with routine checking of electronic laboratory equipment and the design and maintenance of manufacturing equipment, including significant leaks.