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

Source: https://www.keypedia.com/records/483/japan-food-research-laboratories-chitose-laboratory/593707f5-6253-43e0-be01-97777a1f470a

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

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## Details

- Record Type: 483
- Company Name: Japan Food Research Laboratories, Chitose Laboratory
- Product Type: biologics
- Office Name: Office of Inspections and Investigations
- Summary: 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.

## Related Documents

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- [483 - Unknown Date](https://www.keypedia.com/records/483/japan-food-research-laboratories-chitose-laboratory/18be05d6-20aa-4f86-87e7-4d9afb3246c3)

## 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/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8