# FDA 483 - DSAART LLC - June 26, 2025

Source: https://www.globalkeysolutions.net/records/483/dsaart-llc/be7a1b3e-9d54-4f9e-93dd-388690193453

> FDA 483 for DSAART LLC on June 26, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DSAART LLC
- Inspection Date: 2025-06-26
- Product Type: device
- Office Name: San Francisco District Office
- Summary: 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.

## Related Documents

- [483 - 2019-05-15](https://www.globalkeysolutions.net/records/483/dsaart-llc/ba346fd3-aff8-4034-9090-e6da7db6a9da)
- [483 - 2021-08-05](https://www.globalkeysolutions.net/records/483/dsaart-llc/bdde3ada-5cd8-4a86-a29b-40ee09a4d832)
- [483 - 2022-10-14](https://www.globalkeysolutions.net/records/483/dsaart-llc/34dfb301-4b40-435c-927d-03360a44d59f)
- [483 - 2024-03-01](https://www.globalkeysolutions.net/records/483/dsaart-llc/122c5b52-0b7b-4336-b4f3-af5cf1c5052f)

## Related Officers

- [Marlo-Ian M. Alintanahin](https://www.globalkeysolutions.net/people/marlo-ian-m-alintanahin/a37da927-b369-4753-b275-41743556f25e)
- [investigator](https://www.globalkeysolutions.net/people/matthew-m-vernon/f77e8c18-8614-49e3-9b19-3327b7fe7648)

Company: https://www.globalkeysolutions.net/companies/dsaart-llc/6d3cf257-06f9-41e1-ab93-06e44b8edc92

Office: https://www.globalkeysolutions.net/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df