FDA Inspection
Biosensors Interventional Technologies Pte LtdBiosensors Interventional Technologies Pte Ltd – FDA Inspection, Apr 20, 2023
Record Details
This FDA Inspection record concerns Biosensors Interventional Technologies Pte Ltd, with an inspection on April 20, 2023, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 20, 2023
- Product Type
- Devices
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ID · ec33bda8-e32a-450f-adde-9c82461a48d5
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1202978
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
10- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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Other FDA inspections of Biosensors Interventional Technologies Pte Ltd
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 24, 2016 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 5, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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