Company
SingaporeSivantos PTE LTD, Singapore, Singapore – FDA Inspections
Inspection records and compliance data for Sivantos PTE LTD in Singapore. 2 FDA inspections on record, 2 Form 483s, last inspected March 30, 2023.
Company Profile
This profile covers Sivantos PTE LTD based in Singapore, Singapore.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected July 26, 2018. Last inspected March 30, 2023.
Most cited issue areas
- Lack of or inadequate procedures1 inspection
- Lack of Written MDR Procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 30, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1202193 |
| July 26, 2018 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1062325 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Sivantos PTE LTD
FEI Number
3003426343
Address
18 Tai Seng Street, #08-08 18 Tai Seng, Singapore, Singapore
Country
Singapore
ID: 007f14ae-7a87-48fe-95ff-cac5ff89930c