# FDA 483 - Boston Scientific Medical Device (Malaysia) Sdn. Bhd. - November 05, 2018

Source: https://www.keypedia.com/records/483/boston-scientific-medical-device-malaysia-sdn-bhd/dbcd223d-d6bd-43d6-938b-ce9d14a5b2eb

> FDA 483 for Boston Scientific Medical Device (Malaysia) Sdn. Bhd. on November 05, 2018. Product: devices. 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: 2018-11-05
- Product Type: devices
- Office Name: Center for Devices and Radiological Health
- Summary: The provided content exclusively details a Freedom of Information Act (FOIA) request (2018-10345), including its release date of October 19, 2020, and contact information for the FDA/CDRH/OCE/DID. Crucially, it lacks any substantive information typically found within an FDA 483 document. This critical absence means that essential components required for the requested summary, such as the specific company name, the duration or dates of the inspection, any identified main violations, observations, or issues, the pertinent regulatory framework under which these observations were made, or any explicit required actions or follow-up, are completely missing. Consequently, it is not feasible to generate a concise, professional summary ranging between 150 and 300 words that adheres to the specified requirements, as the core data necessary for extracting and synthesizing this information is not present in the input. To produce the desired summary of an FDA 483 document, the actual text or relevant details from such a document would be required.

## Related Officers

- [General Manager](https://www.keypedia.com/people/david-l-mitchell/21509318-31e2-487d-920d-a8f6cfd373a2)
- [Thai T. Duong](https://www.keypedia.com/people/thai-t-duong/59737092-2f30-43a7-b23b-36fa7f212c4a)

Company: https://www.keypedia.com/companies/boston-scientific-medical-device-malaysia-sdn-bhd/a896d17e-1188-4447-9f33-e7e0a4d1e3d6

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7