# FDA 483 - NIPRO CORP. - July 05, 2018

Source: https://www.globalkeysolutions.net/records/483/nipro-corp/92df3935-1f99-4f04-af85-e76749faed66

> FDA 483 for NIPRO CORP. on July 05, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NIPRO CORP.
- Inspection Date: 2018-07-05
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Nipro Corporation - Odate Factory in Odate, Japan, revealed significant deficiencies in process validation for their PATHFAST® cTnI reagent cartridge kits. The firm failed to adequately validate manufacturing processes, citing issues with single-lot validation, insufficient sample size justification, and the absence of an Operational Qualification. These findings indicate a lack of robust quality control in their medical device manufacturing.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/stanley-b-eugene/4708f43e-0592-4c24-b276-d9f9092788a3)

Company: https://www.globalkeysolutions.net/companies/nipro-corp/5a61a305-4198-40c8-a1fa-a8c07ec96acc

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