# FDA 483 - DSAART LLC - October 14, 2022

Source: https://www.globalkeysolutions.net/records/483/dsaart-llc/34dfb301-4b40-435c-927d-03360a44d59f

> FDA 483 for DSAART LLC on October 14, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DSAART LLC
- Inspection Date: 2022-10-14
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: 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.

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## Related Officers

- [Marlo-Ian M. Alintanahin](https://www.globalkeysolutions.net/people/marlo-ian-m-alintanahin/a37da927-b369-4753-b275-41743556f25e)

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

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b