483
Japan Food Research Laboratories, Chitose LaboratoryFDA 483 - Japan Food Research Laboratories, Chitose Laboratory
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Record Details
During an inspection from November 5 to November 8, 2019, the FDA observed that Japan Food Research Laboratories in Chitose, Hokkaido, Japan, failed to fully validate its Pyrogen Test System. This system writes raw and summarized test data into uncontrolled and editable MS Excel files, which are used to determine test results for drug product lots.
- Product Type
- Biologics
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ID · 593707f5-6253-43e0-be01-97777a1f470a