483
TAYCA CORPORATIONTAYCA CORPORATION – FDA 483, Dec 1, 2023
Record Details
An FDA inspection of Tayca Corporation, an API manufacturer in Okayama, Japan, revealed significant deficiencies in their cleaning validation procedures. The firm failed to periodically verify the effectiveness of validated cleaning procedures for non-dedicated equipment and lacked scientific data to support clean and dirty hold times. These issues indicate a lack of robust quality control in their manufacturing processes.
View Company Profile
ID · 72668c3b-2759-4c96-a26b-e182744f7871
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.