DSAART LLCJune 26, 2025

FDA 483 - DSAART LLC - June 26, 2025

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Record Details

DSAART LLC received a Form FDA 483 citing numerous deficiencies across its quality system, including inadequate corrective and preventive actions, unvalidated manufacturing processes, and a lack of established design controls. The inspection also highlighted issues with complaint handling, late MDR submissions, and insufficient risk analysis, indicating systemic failures in maintaining a compliant quality management system.

Company: DSAART LLC
Inspection Date: June 26, 2025
Product Type: Device
Office: San Francisco District Office
People: Matthew M. Vernon (investigator)
Marlo-Ian M. Alintanahin

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ID · be7a1b3e-9d54-4f9e-93dd-388690193453