# FDA 483 - Inno Health Technology, Inc. - September 07, 2023

Source: https://www.globalkeysolutions.net/records/483/inno-health-technology-inc/dc9cfc42-f3ca-487f-af5c-f7a70e85d0ad

> FDA 483 for Inno Health Technology, Inc. on September 07, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Inno Health Technology, Inc.
- Inspection Date: 2023-09-07
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Inno Health Technology, Inc. in Taichung, Taiwan, from September 5-7, 2023, revealed significant deficiencies across multiple quality system areas. The firm's procedures for medical device reporting, complaint handling, nonconforming product, management review, environmental controls, and calibration were found to be inadequate. These issues indicate a lack of robust quality system implementation and compliance with regulatory requirements.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

Company: https://www.globalkeysolutions.net/companies/inno-health-technology-inc/a6adc949-b8d4-459f-9e33-76f29f4d15c1

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