# FDA 483 - General Meditech Inc - August 22, 2024

Source: https://www.keypedia.com/records/483/general-meditech-inc/0895e9cd-cf58-409f-8722-b39d3f4a2942

> FDA 483 for General Meditech Inc on August 22, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: General Meditech Inc
- Inspection Date: 2024-08-22
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: General Meditech Inc., a medical device manufacturer in Shenzhen, China, was cited for multiple quality system deficiencies during an FDA inspection. Key issues include inadequate procedures for corrective and preventive actions, medical device reporting, environmental controls, and document control. The firm also failed to properly document rework activities and provide correct Unique Device Identifier information to the FDA.

## Related Officers

- [Joshua J. Silvestri](https://www.keypedia.com/people/joshua-j-silvestri/433e29b3-ce5f-44d2-9984-7a6cb61e1824)

Company: https://www.keypedia.com/companies/general-meditech-inc/7fbe9344-de29-418e-95a3-23330acea444

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