483
Chugai Pharma Manufacturing Co. Ltd.Chugai Pharma Manufacturing Co. Ltd. – FDA 483, Feb 21, 2020
Record Details
Chugai Pharma Manufacturing Co. Ltd in Utsunomiya, Japan, a drug product manufacturer, was cited for significant deficiencies in its manufacturing processes. The inspection revealed failures to establish and follow appropriate procedures to prevent microbiological contamination of sterile drug products, specifically concerning aseptic and sterilization process validation. Additionally, the firm's test methods were found to be inadequately validated or verified.
View Company Profile
ID · 6d845505-2d19-4be5-b738-c8af14de1380
Other documents for Chugai Pharma Manufacturing Co. Ltd.
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.