# FDA 483 - SSN MEDICAL PRODUCTS SDN BHD - May 10, 2023

Source: https://www.globalkeysolutions.net/records/483/ssn-medical-products-sdn-bhd/8ae00bcf-8dfa-4521-9874-d09eec0dad42

> FDA 483 for SSN MEDICAL PRODUCTS SDN BHD on May 10, 2023. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: SSN MEDICAL PRODUCTS SDN BHD
- Inspection Date: 2023-05-10
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: SSN MEDICAL PRODUCTS SDN BHD, a foreign medical device manufacturer in Seri Kembangan, Malaysia, was inspected by the FDA from May 8-10, 2023. The inspection revealed significant deficiencies in the firm's quality system, specifically regarding document control, device history records, and complaint handling procedures. These issues indicate a lack of adequate controls for ensuring product quality and regulatory compliance.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/ssn-medical-products-sdn-bhd/07bd96e6-cef0-4fa7-97e9-feb224225663

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