# FDA 483 - UniSoft Medical Corporation - January 19, 2023

Source: https://www.keypedia.com/records/483/unisoft-medical-corporation/516d83bc-972f-494a-ad51-487aefc2e59a

> FDA 483 for UniSoft Medical Corporation on January 19, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: UniSoft Medical Corporation
- Inspection Date: 2023-01-19
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of UniSoft Medical Corporation, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to establish adequate procedures for design control and finished device acceptance for their Unisoft One Mattress System. Additionally, the device history records lacked unique device identifiers and submission to the Global Unique Device Identification Database.

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Company: https://www.keypedia.com/companies/unisoft-medical-corporation/d991463b-7ea1-446a-9b9b-739ed446b58d

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