483
Japan Food Research Laboratories, Chitose LaboratoryFDA 483 - Japan Food Research Laboratories, Chitose Laboratory
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 Japan Food Research Laboratories in Chitose, Japan, identified a significant issue regarding their Pyrogen Test System. The system, used for drug product testing, was found to be unvalidated, and its raw and summarized test data were stored in uncontrolled and editable MS Excel files. This raises concerns about data integrity and the reliability of test results for drug products.
- Product Type
- Drugs
- Person
Open in Dashboard
ID · 18be05d6-20aa-4f86-87e7-4d9afb3246c3