Company
SingaporeBiosensors Interventional Technologies Pte Ltd, Singapore, Singapore – FDA Inspections
Inspection records and compliance data for Biosensors Interventional Technologies Pte Ltd in Singapore. 3 FDA inspections on record (2 OAI), 1 Form 483, 1 warning letter, last inspected April 20, 2023.
Company Profile
This profile covers Biosensors Interventional Technologies Pte Ltd based in Singapore, Singapore.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 2
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 1
First inspected August 5, 2010. Last inspected April 20, 2023.
Most cited issue areas
- Design review - Lack of or inadequate procedures1 inspection
- Design transfer - Lack of or inadequate procedures1 inspection
- Documentation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 20, 2023 | OAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1202978 |
| March 24, 2016 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 967282 |
| August 5, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 678586 |
FDA documents
Form 483s (1)
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Biosensors Interventional Technologies Pte Ltd
FEI Number
3002806593
Address
36 Jalan Tukang, Singapore, Singapore
Country
Singapore
ID: 979686ab-2f89-457d-a739-4aa8e9afee7e