# FDA 483 - Nipro (Thailand) Corporation Limited - May 03, 2018

Source: https://www.keypedia.com/records/483/nipro-thailand-corporation-limited/678ad3c4-9c09-455b-baa1-b59e998d1e27

> FDA 483 for Nipro (Thailand) Corporation Limited on May 03, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nipro (Thailand) Corporation Limited
- Inspection Date: 2018-05-03
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Nipro (Thailand) Corporation Limited, a medical device manufacturer, revealed significant deficiencies in their quality system. Observations included inadequate documentation of design validation results, insufficient procedures for handling customer complaints, and failures in maintaining device history records. These issues indicate a need for improved record-keeping and complaint management practices.

## Related Officers

- [investigator](https://www.keypedia.com/people/kwong-p-lee/f4778925-1fad-4988-9e39-86482896c4fa)

Company: https://www.keypedia.com/companies/nipro-thailand-corporation-limited/b1c756f0-a820-4d21-b14e-673b7aa05902

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