# FDA 483 - Hitachi High-Technologies Corp., Omuta Center - February 28, 2019

Source: https://www.keypedia.com/records/483/hitachi-high-technologies-corp-omuta-center/0e1e9f73-f611-4769-a6f4-643409fe6dcb

> FDA 483 for Hitachi High-Technologies Corp., Omuta Center on February 28, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hitachi High-Technologies Corp., Omuta Center
- Inspection Date: 2019-02-28
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: During an inspection of Hitachi High-Technologies Corp.'s Omuta Center in Japan, the FDA observed two significant issues. The firm failed to maintain the acceptance status of products and lacked adequate procedures to prevent contamination in its manufacturing clean room. These conditions indicate deficiencies in quality control and environmental monitoring.

## Related Officers

- [Investigator](https://www.keypedia.com/people/stephen-c-smith/426649fa-0e5b-4b35-ba41-636512a06a48)

Company: https://www.keypedia.com/companies/hitachi-high-technologies-corp-omuta-center/ced112f9-57a2-4537-b736-51081f990faa

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd