483
Lonza Biologics, Inc.FDA 483 - Lonza Biologics, Inc. - July 21, 2023
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
An FDA inspection of Lonza Biologics, Inc. in Portsmouth, NH, revealed a significant issue regarding the qualification of critical manufacturing equipment. The firm failed to adequately qualify a Grade A bottle filler, specifically in demonstrating unidirectional airflow during both static and dynamic operations. This deficiency raises concerns about the control of the aseptic processing environment for drug substance manufacturing.
- Person
Open in Dashboard
ID · 868ee773-89d9-4285-aa55-f226970279fa