483
International Chemical Entity Japan Co., Ltd.FDA 483 - International Chemical Entity Japan Co., Ltd. - March 18, 2019
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.
Record Details
An FDA inspection of API Corporation, an API manufacturer in Iwaki, Fukushima, Japan, revealed significant deficiencies in their laboratory controls. The firm failed to establish scientifically sound specifications and test procedures, leading to issues like unvalidated methods and unsecured analytical equipment. Additionally, the inspection found that complete electronic raw data from critical laboratory tests were not being maintained.
Open in Dashboard
ID · 79e481e7-6b6b-4dc7-a57b-07261d6c5cb6