# FDA 483 - Culligan Soft Water Service Co - July 14, 2023

Source: https://www.globalkeysolutions.net/records/483/culligan-soft-water-service-co/b22f577c-44b2-400d-aeaf-c4332a0b1819

> FDA 483 for Culligan Soft Water Service Co on July 14, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Culligan Soft Water Service Co
- Inspection Date: 2023-07-14
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Culligan Soft Water Service Co in Minnetonka, MN, was inspected and cited for multiple quality system deficiencies related to the manufacture and servicing of deionizer and activated carbon tanks for dialysis water. Key issues include inadequate procedures for non-conforming product, corrective and preventive actions, personnel training, equipment calibration and maintenance, and service verification. The findings indicate a systemic breakdown in maintaining a compliant quality system.

## Related Officers

- [Albert L. Nguyen](https://www.globalkeysolutions.net/people/albert-l-nguyen/496338d0-71c4-43da-92f0-09515559d9fc)

Company: https://www.globalkeysolutions.net/companies/culligan-soft-water-service-co/7e28abe5-0098-4d25-b5eb-a5931dbe15a4

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d