# FDA 483 - Imediplus Inc. - February 22, 2019

Source: https://www.keypedia.com/records/483/imediplus-inc/20015565-bb04-4492-8805-9befbcc57e3f

> FDA 483 for Imediplus Inc. on February 22, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Imediplus Inc.
- Inspection Date: 2019-02-22
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Imediplus Inc., a medical device manufacturer in Chupei City, Taiwan, received two observations during an FDA inspection. The inspection revealed deficiencies in design validation, specifically regarding the documentation of test equipment used for software validation. Additionally, the firm failed to include descriptions of changes in its records for various critical documents.

## Related Officers

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

Company: https://www.keypedia.com/companies/imediplus-inc/b67ae7fe-e878-4a98-983b-ef03d58abe6a

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