# FDA 483 - MedDev Manufacturing Sdn Bhd - May 04, 2023

Source: https://www.globalkeysolutions.net/records/483/meddev-manufacturing-sdn-bhd/4a1a7251-9f0c-4e87-8653-6586e558b0c6

> FDA 483 for MedDev Manufacturing Sdn Bhd on May 04, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MedDev Manufacturing Sdn Bhd
- Inspection Date: 2023-05-04
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: MedDev Manufacturing Sdn Bhd, a foreign medical device manufacturer in Klang, Malaysia, was inspected by the FDA. The inspection revealed two significant observations concerning inadequate record-keeping and document control procedures. Specifically, the firm failed to adequately establish device history record procedures and maintain document control procedures.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/meddev-manufacturing-sdn-bhd/47210d92-4674-475e-b165-87d96bd7bf93

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