FDA 483 - UniSoft Medical Corporation - January 19, 2023

UniSoft Medical Corporation, a medical device manufacturer, underwent an FDA inspection from January 17-19, 2023. The inspection identified three key observations related to their quality system, as outlined under the Federal Food, Drug, and Cosmetic Act, for their Unisoft One Mattress System. The first observation noted a lack of established procedures for design controls. Specifically, bleach compatibility testing for the mattress system was found inadequate, not addressing repeated bleach usage, failing to define sodium hypochlorite percentages, lacking justification for sample sizes, and not considering potential bleach residuals from cleaning processes.

The second observation concerned the absence of established procedures for finished device acceptance. The firm's Device History Records and quality testing lacked traceability between mattress bladders and serial numbers, making it unclear how passing devices were serialized and how failed nonconforming units were consistently scrapped. Lastly, the third observation indicated that Device History Records did not include or reference Unique Device Identifiers (UDI) or Universal Product Codes (UPC), and the UDI for the Unisoft One Mattress had not been submitted to the Global Unique Device Identification Database.

UniSoft Medical Corporation acknowledged these observations and committed to implementing corrective actions to address each identified deficiency.