# FDA 483 - KOWA CO. LTD. CHOFU - July 05, 2018

Source: https://www.globalkeysolutions.net/records/483/kowa-co-ltd-chofu/7549379d-0c7e-4010-96f6-bbc52d42f306

> FDA 483 for KOWA CO. LTD. CHOFU on July 05, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: KOWA CO. LTD. CHOFU
- Inspection Date: 2018-07-05
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: KOWA CO. LTD. CHOFU, a medical device manufacturer in Chofu, Tokyo, Japan, was inspected by the FDA. The inspection resulted in two observations concerning the firm's quality system. Specifically, the firm failed to establish acceptance criteria for validation activities related to a firmware change for a Class 2 fundus camera and lacked established procedures for maintaining device history records.

## Related Documents

- [483 - 2018-07-02](https://www.globalkeysolutions.net/records/483/kowa-co-ltd-chofu/13799fb3-a2ef-4e45-8e59-ea8b77dc4c92)

## Related Officers

- [Jocelyn E. Massey](https://www.globalkeysolutions.net/people/jocelyn-e-massey/4335ffa9-e62c-4139-ba24-fad4845d60c4)

Company: https://www.globalkeysolutions.net/companies/kowa-co-ltd-chofu/b31d7629-c044-4b1a-b856-7bbeae463dc7

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