FDA WARNING_LETTER - VITANG TECHNOLOGY LLC - January 31, 2023

On June 12, 2023, the FDA issued a Warning Letter to Vitang Technology LLC following an inspection from January 24-31, 2023. The inspection revealed that Vitang, a manufacturer and distributor of the Class II UniSmile Clear Aligner, cleared under 510(k) K191837, made significant changes to the device without submitting a new 510(k). Specifically, Vitang switched from the cleared Orchestrate 3D software to the non-cleared iRok OrthoRx 4.0 for treatment plan development, which could affect device safety and effectiveness. This renders the devices misbranded under section 502(o) and adulterated under section 501(f)(1)(B) of the Act.

The inspection also identified multiple Quality System Regulation (QSR) violations, indicating the firm's manufacturing processes are not in conformity with 21 CFR Part 820. Violations include: 1. Failure to adequately establish and maintain complaint handling procedures (21 CFR 820.198), including determining reportability to FDA, investigating device failures, and receiving oral complaints. 2. Failure to validate software used as part of the quality system, specifically the Ruby on Rails complaint handling system (21 CFR 820.70(i)). 3. Failure to