# FDA 483 - Boston Scientific Medical Device (Malaysia) Sdn. Bhd. - November 09, 2018

Source: https://www.globalkeysolutions.net/records/483/boston-scientific-medical-device-malaysia-sdn-bhd/a8d5e19f-d732-4033-9e8c-71ee0c5f0a4b

> FDA 483 for Boston Scientific Medical Device (Malaysia) Sdn. Bhd. on November 09, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Boston Scientific Medical Device (Malaysia) Sdn. Bhd.
- Inspection Date: 2018-11-09
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Boston Scientific Medical Device (Malaysia) Sdn. Bhd. in Bandar Cassia, Malaysia, revealed two significant observations. The firm failed to validate critical mixing processes used in the manufacturing of LOTUS Edge Valve Implants. Additionally, process control procedures for these implants were incomplete, lacking requirements for documenting all operations in the electronic Device History Record.

## Related Officers

- [Thai T. Duong](https://www.globalkeysolutions.net/people/thai-t-duong/59737092-2f30-43a7-b23b-36fa7f212c4a)

Company: https://www.globalkeysolutions.net/companies/boston-scientific-medical-device-malaysia-sdn-bhd/361f4e0e-1ea6-4cf2-970a-6e0334f68282

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