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FDA establishment 3007153372, Minnetonka, Minnesota, United States. Part of Culligan Soft Water Service Co.'s FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 4
Official action indicated: 0
Last inspection ended: Jul 30, 2026
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 0 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
02018Inspections0
120192019Inspections1vs 2018+1
02020Inspections0vs 2019−1
020212021Inspections0vs 2020+0
02022Inspections0vs 2021+0
120232023Inspections1vs 2022+1
02024Inspections0vs 2023−1
020252025Inspections0vs 2024+0
12026Inspections1vs 2025+1
020272027 to dateInspections0
Most Cited at This Site
Inspections citing each reference
ISO 13485:2016 Clause 7.4.1: Supplier performance not monitored1
ISO 13485:2016 Clause 5.6.1: QMS not reviewed by top management at documented planned intervals1
ISO 13485:2016 Clause 7.6(a): Measuring equipment not adequately calibrated or verified1
ISO 13485:2016 Clause 8.5.2: Corrective action not taken1
ISO 13485:2016 Clause 7.4.1. Supplier performance not monitored Supplier performance in meeting requirements for the purchased product was not adequately monitored.
ISO 13485:2016 Clause 5.6.1. QMS not reviewed by top management at documented planned intervals Top management did not adequately review the quality management system at documented planned intervals to ensure its continued suitability, adequacy, and effectiveness.
ISO 13485:2016 Clause 7.6(a). Measuring equipment not adequately calibrated or verified Measuring equipment was not calibrated at specified intervals or prior to use.
ISO 13485:2016 Clause 8.5.2. Corrective action not taken Corrective action was not adequately taken to eliminate the cause of nonconformities in order to prevent recurrence.
21 CFR 801.20(a). Label to bear a unique device identifier The labels of the medical device(s) do not bear a unique device identifier (UDI) that meet the requirements of 801 Subpart B and 21 CFR 830.
21 CFR 820.70(g)(1). Maintenance schedule, Lack of or inadequate schedule Schedules for the adjustment, cleaning, and other maintenance of equipment have not been established.
21 CFR 820.72(a). Calibration, Inspection, etc. Procedures Lack of or Inadequ Procedures to ensure equipment is routinely calibrated and maintained have not been adequately established.
21 CFR 820.200(a). Servicing - Lack of or inadequate procedures Procedures or instructions for verifying that servicing meets specified requirements have not been adequately established.
21 CFR 820.25(b). Training records Personnel training is not documented.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
21 CFR 820.90(a). Nonconforming product, Lack of or inadequate procedures Procedures have not been established to control product that does not conform to specified requirements.
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard, warning letters and enforcement reports
Minnetonka, Minnesota, United States. Part of