# FDA 483 - Better Water LLC - June 26, 2025

Source: https://www.globalkeysolutions.net/records/483/better-water-llc/447530ce-1140-4e13-a86a-b715a54411f6

> FDA 483 for Better Water LLC on June 26, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Better Water LLC
- Inspection Date: 2025-06-26
- Product Type: other
- Office Name: New Orleans District Office
- Summary: Better Water LLC in Smyrna, TN, was inspected by the FDA, resulting in two observations. The inspection revealed issues with the validation of software used in the quality system and insufficient documentation of labels and labeling in Device History Records. These findings indicate deficiencies in the firm's quality management and record-keeping practices.

## Related Documents

- [483 - 2022-07-26](https://www.globalkeysolutions.net/records/483/better-water-llc/afb00722-a76d-4e31-bec0-50c47c67e68c)

## Related Officers

- [Elizabeth A. Krolczyk](https://www.globalkeysolutions.net/people/elizabeth-a-krolczyk/ecf57c43-b88d-4f84-962b-9067eaad4a7c)

Company: https://www.globalkeysolutions.net/companies/better-water-llc/b12935ac-d3c6-48b4-b65e-62c73611b9f5

Office: https://www.globalkeysolutions.net/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea