483
Grand River Aseptic Manufacturing, Inc.FDA 483 - Grand River Aseptic Manufacturing, Inc. - September 19, 2024
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 Grand River Aseptic Manufacturing Inc. in Grand Rapids, MI, identified two significant observations. The firm failed to adequately simulate all manufacturing processing steps during a fill validation study for a syringe filling line. Additionally, unplanned operational activities and interventions were not timely documented in manufacturing batch records.
- Inspection Date
- September 19, 2024
- Product Type
- Biologics
Open in Dashboard
ID · 37abd61f-8bd2-44d4-a17b-58712d4812a3