FDA Inspection 1330928 — Culligan Soft Water Service Company
The FDA completed an inspection of Culligan Soft Water Service Company on Jul 30, 2026 in Minnetonka, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 30, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Minnetonka, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22795 | 21 CFR 801.20(a) | Label to bear a unique device identifier |
| 23061 | ISO 13485:2016 Clause 5.6.1 | QMS not reviewed by top management at documented planned intervals |
| 23142 | ISO 13485:2016 Clause 7.4.1 | Supplier performance not monitored |
| 23194 | ISO 13485:2016 Clause 7.6(a) | Measuring equipment not adequately calibrated or verified |
| 23255 | ISO 13485:2016 Clause 8.5.2 | Corrective action not taken |