483
UniSoft Medical CorporationUniSoft Medical Corporation – FDA 483, Jan 19, 2023
Record Details
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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ID · 516d83bc-972f-494a-ad51-487aefc2e59a
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