# FDA 483 - Nurse Assist, LLC - September 21, 2023

Source: https://www.keypedia.com/records/483/nurse-assist-llc/985d5adb-e207-423a-822e-ccf4846270a8

> FDA 483 for Nurse Assist, LLC on September 21, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nurse Assist, LLC
- Inspection Date: 2023-09-21
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Nurse Assist, LLC received an FDA Form 483 citing significant deficiencies in their quality system, primarily focusing on inadequate validation of manufacturing processes for water-based medical devices. The observations highlight failures in controlling nonconforming products, implementing effective corrective and preventive actions, and maintaining proper environmental controls. The report also notes issues with equipment maintenance, supplier controls, and the timely reporting of adverse events.

## Related Officers

- [investigator](https://www.keypedia.com/people/christine-i-shaw/480cb61e-f173-432d-b84a-c8b492192302)
- [Jacey Koy](https://www.keypedia.com/people/jacey-koy/4ac4d4b9-cd7c-4e2a-968e-4a37a21cb6a8)
- [Terri E. Gibson](https://www.keypedia.com/people/terri-e-gibson/f1a80f95-a5c4-4cae-9a4b-e23f367770bb)

Company: https://www.keypedia.com/companies/nurse-assist-llc/340b5e01-8ff8-4696-aecc-a1a9a5ea2ee5

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab