FDA 483 - Bio-Rad Laboratories, Inc. - October 21, 2019

An FDA inspection of Bio-Rad Laboratories, Inc. in Woodinville, WA, a licensed IVD manufacturer, revealed two significant observations. The firm failed to establish adequate process control procedures, specifically lacking detailed instructions in Manufacturing Batch Records. Additionally, schedules for equipment adjustment, cleaning, and maintenance were not established, and filling machines were observed with cleanliness issues.