# FDA 483 - Evoqua Water Technologies, LLC - February 24, 2022

Source: https://www.globalkeysolutions.net/records/483/evoqua-water-technologies-llc/6158d64a-d694-461c-9f83-15f1d34d0dc6

> FDA 483 for Evoqua Water Technologies, LLC on February 24, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Evoqua Water Technologies, LLC
- Inspection Date: 2022-02-24
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Evoqua Water Technologies, LLC in Lowell, MA, a manufacturer of water treatment systems for dialysis, identified two significant observations. The firm failed to perform internal quality audits at defined intervals for 2019 and 2021 without documented justification. Additionally, device history records for Class II medical devices lacked the required unique device identifier (UDI).

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/stephen-c-smith/426649fa-0e5b-4b35-ba41-636512a06a48)

Company: https://www.globalkeysolutions.net/companies/evoqua-water-technologies-llc/979188df-6b96-4309-9d0c-b91a3dd695fe

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7