# FDA 483 - InfuTronix LLC - February 15, 2022

Source: https://www.keypedia.com/records/483/infutronix-llc/580867b3-ced1-4f14-a028-ca5158c83a57

> FDA 483 for InfuTronix LLC on February 15, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: InfuTronix LLC
- Inspection Date: 2022-02-15
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of InfuTronix LLC in Natick, MA, revealed five significant observations regarding their quality system for medical devices. The firm failed to adequately establish procedures for corrective and preventive actions, properly handle and investigate product complaints, and ensure design validation for their Nimbus infusion pumps. Additionally, deficiencies were noted in supplier management and the timely submission of Medical Device Reports for serious malfunctions, including repeat observations.

## Related Documents

- [WARNING_LETTER - 2022-02-15](https://www.keypedia.com/records/warning_letter/infutronix-llc/e5df945b-61ed-444f-980d-415f93daeb0f)
- [483 - 2023-08-16](https://www.keypedia.com/records/483/infutronix-llc/62ea8c06-5a56-4145-82a7-f600dae800aa)

## Related Officers

- [Sara M. Onyango](https://www.keypedia.com/people/sara-m-onyango/643c6ad3-9747-4bc2-9e8e-72f97b11e659)

Company: https://www.keypedia.com/companies/infutronix-llc/edcd86cd-cf3f-4eef-a9ab-f5e2dc793a73

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