# FDA 483 - Intelligent System Co., Ltd. - May 18, 2023

Source: https://www.keypedia.com/records/483/intelligent-system-co-ltd/31fd1c68-cb50-4657-8c51-ce8e4030db50

> FDA 483 for Intelligent System Co., Ltd. on May 18, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Intelligent System Co., Ltd.
- Inspection Date: 2023-05-18
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Intelligent System Co., Ltd. in Nanto, Japan, a medical device specification developer, received a Form FDA 483 with three observations. The inspection revealed significant deficiencies in the firm's quality system, specifically concerning the lack of adequate written procedures. These issues relate to device servicing, complaint handling, and Medical Device Reporting (MDR).

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/maryam-tabatabaie/b792042d-e296-446d-90a9-d30c8f635506)

Company: https://www.keypedia.com/companies/intelligent-system-co-ltd/944a900c-6614-431e-9386-f52a20e0bb69

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