# FDA 483 - Flowonix Medical Inc - October 11, 2019

Source: https://www.keypedia.com/records/483/flowonix-medical-inc/d9e4774a-68fd-465d-bd77-8b6fa679ca84

> FDA 483 for Flowonix Medical Inc on October 11, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Flowonix Medical Inc
- Inspection Date: 2019-10-11
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Flowonix Medical Inc. in Mansfield, MA, revealed inadequate procedures for handling complaints. Specifically, several complaints concerning the Prometra Pump remained open for over 120 days without documented justification, violating the firm's own complaint procedure. This indicates a significant lapse in the firm's quality system for complaint management.

## Related Officers

- [investigator](https://www.keypedia.com/people/james-p-finn/70e5c36c-2711-449b-bf73-e08b4dd58449)

Company: https://www.keypedia.com/companies/flowonix-medical-inc/dfcff23e-097d-421b-b3ee-89a6661b2ed5

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