FDA 483 - AGC, Inc. - October 27, 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.
AGC Inc. in Ichihara-shi, Chiba, Japan, an API manufacturer, received a Form FDA 483 with three observations. The inspection revealed significant issues with the firm's quality unit, including inadequate analytical procedures, sampling, and specifications for raw materials and finished APIs. Additionally, the firm failed to adequately investigate deviations related to environmental monitoring and out-of-specification results, and lacked proper control over its label storage and printing system.
ID · e0d2ff65-cd21-4d8b-9184-d5c67694dfcf