# FDA 483 - Medimaging Integrated Solution, Inc. - July 05, 2018

Source: https://www.globalkeysolutions.net/records/483/medimaging-integrated-solution-inc/7db8f963-036c-4614-9e7e-112793f25823

> FDA 483 for Medimaging Integrated Solution, Inc. on July 05, 2018. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Medimaging Integrated Solution, Inc.
- Inspection Date: 2018-07-05
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Medimaging Integrated Solution, Inc. in Hsinchu, Taiwan, was inspected by the FDA from April to July 2018, resulting in a Form 483. The inspection revealed significant quality system deficiencies, including a lack of validation for manufacturing processes, inadequate nonconformance data analysis, unqualified suppliers, and insufficient production records for subassemblies. These issues indicate a need for improved quality control and documentation practices.

## Related Officers

- [Ashley A. Mutawakkil](https://www.globalkeysolutions.net/people/ashley-a-mutawakkil/512be391-fd96-451c-9569-98e43cfba9db)

Company: https://www.globalkeysolutions.net/companies/medimaging-integrated-solution-inc/9d276b06-5528-478e-a8eb-e49619b1fa5d

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