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

Source: https://www.keypedia.com/records/483/japan-food-research-laboratories-chitose-laboratory/5e4f7306-c680-41d5-886d-444419e2d284

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

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## Details

- Record Type: 483
- Company Name: Japan Food Research Laboratories, Chitose Laboratory
- Product Type: other
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Japan Food Research Laboratories, a contract testing laboratory in Chitose-shi, Hokkaido, revealed significant deficiencies. Observations included inadequate controls for electronic records, such as lack of unique administrator IDs, unverified data retrieval, common passwords, and infrequent password changes. Additionally, the firm lacked detailed written procedures for sample testing and its quality control unit demonstrated insufficient authority to properly investigate deviations and out-of-specification results.

## Related Documents

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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

- [Cynthia Jim](https://www.keypedia.com/people/cynthia-jim/e0f1c8a7-d787-442a-911c-61e37cd806a6)

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-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1