# FDA 483 - Evoqua Water Technologies LLC - May 14, 2024

Source: https://www.globalkeysolutions.net/records/483/evoqua-water-technologies-llc/0387ecbb-2dbe-4c85-b3bb-555c2f5de378

> FDA 483 for Evoqua Water Technologies LLC on May 14, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Evoqua Water Technologies LLC
- Inspection Date: 2024-05-14
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Evoqua Water Technologies LLC in Buena Park, CA, revealed significant deficiencies in their quality system and medical device labeling and registration. The firm failed to conduct internal quality audits, and their carbon tanks for hemodialysis lacked unique device identifiers (UDI) on labels and were not registered in the Global Unique Device Identification Database (GUDID). Additionally, device history records were incomplete, lacking UDI information, primary identification labels, and raw material identification.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/juanita-banuelos/b8b581ef-b9f3-4d77-a9fa-691223dbb7f4)

Company: https://www.globalkeysolutions.net/companies/evoqua-water-technologies-llc/9c91a656-8f2f-4f57-8320-276aff61fd41

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6