# FDA 483 - Biosensics LLC - April 07, 2023

Source: https://www.keypedia.com/records/483/biosensics-llc/bb89afad-ec4b-46b4-8c79-288e3365cbbe

> FDA 483 for Biosensics LLC on April 07, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biosensics LLC
- Inspection Date: 2023-04-07
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Biosensics LLC, a medical device manufacturer in Newton, MA, identified three significant observations related to their quality system. The firm failed to adequately establish procedures for equipment calibration, corrective and preventive actions, and supplier management. These issues indicate deficiencies in ensuring product quality and compliance with regulatory requirements.

## Related Documents

- [483 - 2026-02-09](https://www.keypedia.com/records/483/biosensics-llc/6592be4b-4391-4734-92e8-88cc3d1c2be7)

## Related Officers

- [Sunita Pandey](https://www.keypedia.com/people/sunita-pandey/008e5bb8-0eb3-45d8-8524-734ac0454250)

Company: https://www.keypedia.com/companies/biosensics-llc/6e562ea7-1ac8-4d2a-966e-5eb9766dfe21

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94