# FDA 483 - Japan Food Research Laboratories, Chitose Laboratory - Unknown Date

Source: https://www.keypedia.com/records/483/japan-food-research-laboratories-chitose-laboratory/18be05d6-20aa-4f86-87e7-4d9afb3246c3

> FDA 483 for Japan Food Research Laboratories, Chitose Laboratory on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Japan Food Research Laboratories, Chitose Laboratory
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: 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.

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- [483 - Unknown Date](https://www.keypedia.com/records/483/japan-food-research-laboratories-chitose-laboratory/593707f5-6253-43e0-be01-97777a1f470a)

## Related Officers

- [Brian D. Nicholson](https://www.keypedia.com/people/brian-d-nicholson/83ea13dd-6753-468a-a0ca-19e3ef4158dd)

Company: https://www.keypedia.com/companies/japan-food-research-laboratories-chitose-laboratory/c3ad3f4b-a344-4b4b-9ad4-8800c23e2218

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321