DSAART LLCOctober 14, 2022

FDA 483 - DSAART LLC - October 14, 2022

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Record Details

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.

Company: DSAART LLC
Inspection Date: October 14, 2022
Product Type: Device
Office: Division of Human and Animal Food Operations - West V
Person: Marlo-Ian M. Alintanahin

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ID · 34dfb301-4b40-435c-927d-03360a44d59f