ISOPURE, CORP. — FDA Facility Profile
ISOPURE, CORP. is an FDA-registered facility (FEI 3013942511) located in Louisville, KY, US. RegDataLab tracks 5 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Aug 15, 2024: Voluntary Action Indicated (VAI)
- Inspections on record
- 5 (4 VAI, 1 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 3, latest Jul 26, 2022
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Aug 15, 2024 | Voluntary Action Indicated (VAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) |
| Oct 21, 2022 | No Action Indicated (NAI) | No citations listed |
| Sep 23, 2019 | Voluntary Action Indicated (VAI) | Records of complaint investigation (21 CFR 820.198(e)) Time to report - 10 days (21 CFR 806.10(b)) |
| Sep 28, 2017 | Voluntary Action Indicated (VAI) | Product rework procedures, Lack of or inadequate procedures (21 CFR 820.90(b)(2)) Lack of or inadequate process validation (21 CFR 820.75(a)) |
| Aug 25, 2011 | Voluntary Action Indicated (VAI) | Documentation (21 CFR 820.100(b)) Report of risk to health (21 CFR 806.10(a)(1)) |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Jul 26, 2022 | Not yet classified | Z-1739-2022 | Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate… Acidified Concentrate Distribution System potential electrical safety hazard may result in electric shock, arching |
| Apr 28, 2022 | Not yet classified | Z-1360-2022 | Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) Isopure received a report of a hazardous incident involving a device which had experienced an electrical short that resulted in a thermal… |
| Apr 19, 2019 | Not yet classified | Z-0821-2020 | Acidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson… and 2 more products There is a potential for an uneven plastic encapsulation of the magnet ring during the molding process and partial axial displacement. This… |
Facility details
- Company
- Isopure Corp.
- Location
- Louisville, KY (US)
- Source
- device