Clinical Laboratories Of Hawaii, Maui Memorial Medical Center FDA Record
- Latest inspection NAI · May 13, 2025
- No warning letters matched by name
Clinical Laboratories Of Hawaii, Maui Memorial Medical Center has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Clinical Laboratories Of Hawaii, Maui Memorial Medical Center" is on file.
- Latest inspection
- May 13, 2025 · NAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 0 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 5 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Clinical Laboratories Of Hawaii, Maui Memorial Medical Center: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 13, 2025 | Wailuku, HI | Biologics | No Action Indicated (NAI) | 3007930094 |
| May 2, 2018 | Wailuku, HI | Biologics | No Action Indicated (NAI) | 3007930094 |
| Apr 7, 2016 | Wailuku, HI | Biologics | No Action Indicated (NAI) | 3007930094 |
| Jul 17, 2014 | Wailuku, HI | Biologics | No Action Indicated (NAI) | 3007930094 |
| Aug 31, 2012 | Wailuku, HI | Biologics | No Action Indicated (NAI) | 3007930094 |
- 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.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3007930094 | Wailuku, HI | 5 | May 13, 2025 |
Clinical Laboratories Of Hawaii, Maui Memorial Medical Center and the FDA: common questions
Has Clinical Laboratories Of Hawaii, Maui Memorial Medical Center received an FDA warning letter?
No FDA warning letter addressed to the name "Clinical Laboratories Of Hawaii, Maui Memorial Medical Center" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Clinical Laboratories Of Hawaii, Maui Memorial Medical Center received an FDA Form 483?
FDA has not published a Form 483 for "Clinical Laboratories Of Hawaii, Maui Memorial Medical Center" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Clinical Laboratories Of Hawaii, Maui Memorial Medical Center?
The most recent FDA inspection on file ended May 13, 2025 at Wailuku, HI and was classified NAI. FDA has 5 inspections of Clinical Laboratories Of Hawaii, Maui Memorial Medical Center on file.
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