# FDA 483 - Plaxtron Industrial (M) SDN. BHD. - August 15, 2024

Source: https://www.globalkeysolutions.net/records/483/plaxtron-industrial-m-sdn-bhd/b18ef45b-fbb4-43b8-aad2-bfc33cec02c7

> FDA 483 for Plaxtron Industrial (M) SDN. BHD. on August 15, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Plaxtron Industrial (M) SDN. BHD.
- Inspection Date: 2024-08-15
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Plaxtron Industrial (M) SDN. BHD. in Ipoh, Malaysia, was inspected by the FDA from August 12-15, 2024, and received six observations. The inspection revealed significant deficiencies in process validation, device history records, process monitoring, environmental controls, corrective and preventive actions, and equipment maintenance procedures. These issues indicate a systemic lack of adequate quality system controls for medical device manufacturing.

## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/christina-l-bigham/f3da8e26-4a8c-43a8-8070-349fe4500289)

Company: https://www.globalkeysolutions.net/companies/plaxtron-industrial-m-sdn-bhd/322ea42a-67dc-413e-a339-ab8e3fa02a98

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