FDA Inspection
Culligan Soft Water Service CoCulligan Soft Water Service Co – FDA Inspection, Jul 30, 2026
Record Details
This FDA Inspection record concerns Culligan Soft Water Service Co, with an inspection on July 30, 2026, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 22907c71-ef84-498a-999a-85c443e54e93
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1330928
- Project area
- Compliance: Devices
FDA Citations
8- ISO 13485:2016 Clause 8.5.2Corrective action not taken
- ISO 13485:2016 Clause 7.1Supplier performance not monitored
- 21 CFR 801(a)Label to bear a unique device identifier
- ISO 13485:2016 Clause 7.6(a)Measuring equipment not adequately calibrated or verified
- ISO 13485:2016 Clause 8.5.1QMS not reviewed by top management at documented planned intervals
- 21 CFR 801.20(a)Label to bear a unique device identifier
- ISO 13485:2016 Clause 5.6.1QMS not reviewed by top management at documented planned intervals
- ISO 13485:2016 Clause 7.4.1Supplier performance not monitored
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Culligan Soft Water Service Co
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 14, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 7, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 14, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Culligan Soft Water Service Co
- FDA Inspection 1210229 - 2023-07-14
- FDA Inspection 1084689 - 2019-03-07
- FDA Inspection 952452 - 2015-12-14
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