# FDA 483 - OHIRA CO., LTD - February 27, 2020

Source: https://www.keypedia.com/records/483/ohira-co-ltd/ef8f7bfc-9f2c-40f5-8020-bf25d334cf64

> FDA 483 for OHIRA CO., LTD on February 27, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: OHIRA CO., LTD
- Inspection Date: 2020-02-27
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of OHIRA CO., LTD in Minamiuonuma-shi, Japan, revealed significant deficiencies in their device history record (DHR) procedures. The firm failed to adequately establish DHR procedures to ensure devices were manufactured according to the device master record (DMR). Additionally, reviewed DHRs lacked essential information such as primary identification labels, labeling, and unique device identifiers.

## Related Officers

- [Christopher B. May](https://www.keypedia.com/people/christopher-b-may/b2173a59-d37b-41f1-aa39-eefd854722b8)

Company: https://www.keypedia.com/companies/ohira-co-ltd/d77c8cb9-60ee-4558-a845-d3f54be96475

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