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Isopure Corp

FDA Regulatory Profile

Isopure Corp has 5 FDA recalls, 7 inspections, 5 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Isopure Corp" and its spelling variants "Isopure", "Isopure Company".

Latest recall
Z-1739-2022 · Class II · Jul 26, 2022
Latest inspection
Aug 15, 2024 · VAI
Latest 510(k)
Jan 22, 2020

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls5Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances5Nov 8, 2026File dated Nov 2, 2026Current
Inspections7Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Isopure Corp's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Isopure Corp: FDA inspections per year 2017: 1 inspections120172018: 0 inspections020182019: 1 inspections120192020: 0 inspections020202021: 0 inspections020212022: 1 inspections120222023: 0 inspections020232024: 1 inspections120242025: 0 inspections020252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202410000
202300000
202210020
202100000
202000000
201910030
201800000
201710000

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent recalls

5 recall records from Apr 19, 2019 to Jul 26, 2022.

NumberClassProductDate
Z-1739-2022Class IIAcidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution…Jul 26, 2022
Z-1360-2022Class IIIsopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)Apr 28, 2022
Z-0821-2020Class IIAcidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson…Apr 19, 2019
Z-0822-2020Class IIIsopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson…Apr 19, 2019
Z-0823-2020Class IIFinish Thompson Centrifugal Pump Model #110192-3 (sold as spare part)Apr 19, 2019

Recent FDA inspections

7 inspections from Aug 25, 2011 to Aug 15, 2024.

DateSiteProductClassificationFEI
Aug 15, 2024Louisville, KYDevicesVoluntary Action Indicated (VAI)3013942511
Oct 21, 2022Louisville, KYDevicesNo Action Indicated (NAI)3013942511
Sep 23, 2019Louisville, KYDevicesVoluntary Action Indicated (VAI)3013942511
Sep 28, 2017Louisville, KYDevicesVoluntary Action Indicated (VAI)3013942511
Jun 6, 2016Garden Grove, CAFood/CosmeticsNo Action Indicated (NAI)3004256712
Jan 13, 2014Webster, MAFood/CosmeticsNo Action Indicated (NAI)3006713606
Aug 25, 2011Louisville, KYDevicesVoluntary Action Indicated (VAI)3013942511
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

3 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3013942511Louisville, KY5Aug 15, 2024
FEI 3004256712Garden Grove, CA1Jun 6, 2016
FEI 3006713606Webster, MA1Jan 13, 2014

Recent 510(k) clearances

5 510(k) clearances from Jan 24, 2000 to Jan 22, 2020.

K-NumberDeviceDate
K191093Isopure Dry Acid Dissolution SystemJan 22, 2020
K120005ACDSMar 29, 2012
K112427BICARB MIXING AND DISTRIBUTION SYSTEMJan 26, 2012
K041163ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIESOct 7, 2004
K993200MD 420/440/460/470/480/490Jan 24, 2000

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FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.