# FDA 483 - Biosensors Interventional Technologies Pte Ltd - April 20, 2023

Source: https://www.keypedia.com/records/483/biosensors-interventional-technologies-pte-ltd/e7f35971-17f3-4eb2-bd1f-3bc442f2e26e

> FDA 483 for Biosensors Interventional Technologies Pte Ltd on April 20, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biosensors Interventional Technologies Pte Ltd
- Inspection Date: 2023-04-20
- Product Type: device
- Office Name: Office of Biological Products Operations - Division I
- Summary: Biosensors Interventional Pte, Ltd. in Singapore was inspected by the FDA from April 17-20, 2023, and received a Form FDA-483 with five observations. The inspection revealed significant deficiencies in corrective and preventive action procedures, complaint handling, medical device reporting (MDR) processes, and process control for their BioFreedom Drug Coated Stent System devices. These issues indicate a lack of adequate quality system implementation for a medical device manufacturer.

## Related Documents

- [WARNING_LETTER - 2023-04-20](https://www.keypedia.com/records/warning_letter/biosensors-interventional-technologies-pte-ltd/a1fc484b-417b-4217-a597-a497e0c3a701)

## Related Officers

- [Joshua J. Silvestri](https://www.keypedia.com/people/joshua-j-silvestri/433e29b3-ce5f-44d2-9984-7a6cb61e1824)

Company: https://www.keypedia.com/companies/biosensors-interventional-technologies-pte-ltd/979686ab-2f89-457d-a739-4aa8e9afee7e

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1