483
Japan Food Research Laboratories, Chitose LaboratoryJapan Food Research Laboratories, Chitose Laboratory – FDA 483
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
View Company Profile
ID · 18be05d6-20aa-4f86-87e7-4d9afb3246c3
Other documents for Japan Food Research Laboratories, Chitose Laboratory
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.