# FDA 483 - Boston Scientific Medical Device (Malaysia) Sdn. Bhd. - May 22, 2026

Source: https://www.keypedia.com/records/483/boston-scientific-medical-device-malaysia-sdn-bhd/937dc9f5-c58b-4009-843c-3f5ca23b19b6

> FDA 483 for Boston Scientific Medical Device (Malaysia) Sdn. Bhd. on May 22, 2026. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Boston Scientific Medical Device (Malaysia) Sdn. Bhd.
- Inspection Date: 2026-05-22
- Product Type: device
- Office Name: Office of Partnerships
- Summary: Boston Scientific Medical Device (Malaysia) Sdn. Bhd., a medical device manufacturer in Seberang Perai Selatan, Malaysia, was cited for significant deficiencies in its laboratory controls and quality system. The inspection revealed inadequate investigations into recurring analytical failures, incomplete laboratory records for testing and equipment, and insufficient controls over the issuance and use of analytical worksheets, raising concerns about data accuracy and integrity.

## Related Documents

- [483 - 2018-11-09](https://www.keypedia.com/records/483/boston-scientific-medical-device-malaysia-sdn-bhd/a8d5e19f-d732-4033-9e8c-71ee0c5f0a4b)

## Related Officers

- [Ashar P. Parikh](https://www.keypedia.com/people/ashar-p-parikh/f5430c51-31c7-44bb-90f7-1ec8ae581343)

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

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3