FDA Inspection
Biosensors Interventional Technologies Pte LtdBiosensors Interventional Technologies Pte Ltd – FDA Inspection, Aug 5, 2010
Record Details
This FDA Inspection record concerns Biosensors Interventional Technologies Pte Ltd, with an inspection on August 5, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 5, 2010
- Product Type
- Devices
View Company Profile
ID · 46319e6d-6403-4aba-836a-774a3927ff44
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 678586
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.100(b)Documentation
- 21 CFR 820.90(b)(2)Product rework adverse effects {see also 820.184}
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.50(a)(2)Supplier oversight
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Other FDA inspections of Biosensors Interventional Technologies Pte Ltd
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 20, 2023 | OAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| March 24, 2016 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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