Company
MalaysiaBoston Scientific Medical Device (Malaysia) Sdn. Bhd., Seberang Perai Selatan, Malaysia – FDA Inspections
Inspection records and compliance data for Boston Scientific Medical Device (Malaysia) Sdn. Bhd. in Seberang Perai Selatan. 2 FDA inspections on record, 1 Form 483, last inspected March 05, 2026.
Company Profile
This profile covers Boston Scientific Medical Device (Malaysia) Sdn. Bhd. based in Seberang Perai Selatan, Malaysia.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 0
- Unclassified
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected November 9, 2018. Last inspected March 5, 2026.
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 5, 2026 | Not classified | Medical Devices & Rad Health | 1316342 |
| November 9, 2018 | Not classified | Medical Devices & Rad Health | 1073575 |
FDA documents
Form 483s (2)
People (2)
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Company Information
Name
Boston Scientific Medical Device (Malaysia) Sdn. Bhd.
FEI Number
3014222368
Address
Pmt 741, Persiaran Cassia Selatan 1, Taman Perindustrian Batu Kawan, Seberang Perai Selatan, Malaysia
Country
Malaysia
ID: 361f4e0e-1ea6-4cf2-970a-6e0334f68282