# FDA 483 - OPULENT SOLUTIONS SDN BHD - May 17, 2023

Source: https://www.keypedia.com/records/483/opulent-solutions-sdn-bhd/1a5b4deb-613b-4c63-9b70-0cc707101727

> FDA 483 for OPULENT SOLUTIONS SDN BHD on May 17, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: OPULENT SOLUTIONS SDN BHD
- Inspection Date: 2023-05-17
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of OPULENT SOLUTIONS SDN BHD, a foreign medical device manufacturer in Bayan Lepas, Malaysia, revealed significant deficiencies in their quality system. The firm failed to establish adequate process control procedures, maintain proper rework procedures for nonconforming products, and effectively implement document control procedures. These observations indicate a need for comprehensive corrective actions to ensure compliance with regulatory requirements.

## Related Officers

- [Dianiris C. Ayala](https://www.keypedia.com/people/dianiris-c-ayala/ba6c5538-201b-4c9a-8f23-e160db6868e6)

Company: https://www.keypedia.com/companies/opulent-solutions-sdn-bhd/a0e20523-15f0-4e40-ab88-1f11b04a0777

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