FDA 483 - DSAART LLC - October 14, 2022

DSAART, LLC in Carson City, NV, was cited for significant deficiencies during an FDA inspection. The firm failed to submit required Medical Device Reports (MDRs) within 30 days for serious device-related complaints and malfunctions. Additionally, the company did not adequately validate critical manufacturing processes, including curing and terminal sterilization, nor did it assess product integrity after these processes or conduct shelf-life studies.