FDA 483 - Titan Kogyo, Ltd. - December 08, 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.
An FDA inspection of Titan Kogyo, Ltd., an API manufacturer in Ube, Japan, revealed significant deficiencies in quality control and manufacturing practices. Observations included the use of critical raw materials before completion of identification testing, an inadequate stability program lacking stability-indicating methods, and insufficient verification testing of raw material supplier Certificates of Analysis. Additionally, equipment and utensils were not adequately cleaned or maintained, leading to potential contamination risks.
ID · 573abd9b-8568-4941-a06d-d98c9cb6b9e8