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Clinical Laboratories Of Hawaii, LLP FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Latest inspection NAI · Aug 21, 2025
No warning letters matched by name

Inspections 17

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Clinical Laboratories Of Hawaii, LLP has 0 FDA recalls, 17 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Clinical Laboratories Of Hawaii, LLP" is on file. FDA has published 1 Form 483 for Clinical Laboratories Of Hawaii, LLP.

What these totals cover: FDA records filed under the name "Clinical Laboratories Of Hawaii, LLP" and its spelling variant "Clinical Laboratories Of Hawaii".

Latest inspection: Aug 21, 2025 · NAI

Summary

Record counts and when each FDA source was last refreshed
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	17	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, LLP's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Clinical Laboratories Of Hawaii, LLP: FDA inspections per year

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	3	0	0	0	0
2024	0	0	0	0	0
2023	1	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	3	0	0	0	0
2017	0	0	0	0	0

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.

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Clinical Laboratories Of Hawaii, LLP Form 483s

1 Form 483 published by FDA.

Date	Document	FEI
May 6, 2025 · Document on fda.gov	483	2974624

A Form 483 lists the observations FDA investigators made at the end of an inspection. FDA publishes some Form 483s in its reading room, and each date links to that document. Read the observations with the FDA 483 search.

Recent FDA inspections

17 inspections from Apr 22, 2009 to Aug 21, 2025.

Date	Site	Product	Classification	FEI
Aug 21, 2025	Honolulu, HI	Biologics	No Action Indicated (NAI)	2972911
Aug 12, 2025	Honolulu, HI	Biologics	No Action Indicated (NAI)	2972911
May 6, 2025	Hilo, HI	Biologics	Voluntary Action Indicated (VAI)	2974624
Jun 15, 2023	Honolulu, HI	Biologics	Voluntary Action Indicated (VAI)	2972911
May 17, 2018	Honolulu, HI	Biologics	No Action Indicated (NAI)	2972911
May 16, 2018	Honolulu, HI	Biologics	Voluntary Action Indicated (VAI)	2972911
Apr 18, 2018	Honolulu, HI	Drugs	No Action Indicated (NAI)	2972911
Aug 25, 2016	Honolulu, HI	Biologics	No Action Indicated (NAI)	2972911
Jun 9, 2016	Honolulu, HI	Biologics	No Action Indicated (NAI)	2972911
Oct 30, 2013	Honolulu, HI	Biologics	No Action Indicated (NAI)	2972911
Aug 20, 2013	Honolulu, HI	Biologics	No Action Indicated (NAI)	2972911
Aug 15, 2011	Honolulu, HI	Biologics	No Action Indicated (NAI)	2971502
Jul 28, 2011	Honolulu, HI	Biologics	Voluntary Action Indicated (VAI)	2972911
Sep 8, 2010	Aiea, HI	Biologics	No Action Indicated (NAI)	3005073801
Jul 9, 2009	Honolulu, HI	Biologics	No Action Indicated (NAI)	2972911
Jul 7, 2009	Honolulu, HI	Biologics	No Action Indicated (NAI)	2972911
Apr 22, 2009	Honolulu, HI	Biologics	Voluntary Action Indicated (VAI)	2971502

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

4 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 2972911	Honolulu, HI	13	Aug 21, 2025
FEI 2974624	Hilo, HI	1	May 6, 2025
FEI 2971502	Honolulu, HI	2	Aug 15, 2011
FEI 3005073801	Aiea, HI	1	Sep 8, 2010

Clinical Laboratories Of Hawaii, LLP and the FDA: common questions

Has Clinical Laboratories Of Hawaii, LLP received an FDA warning letter?

No FDA warning letter addressed to the name "Clinical Laboratories Of Hawaii, LLP" 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, LLP received an FDA Form 483?

FDA has published 1 Form 483 for Clinical Laboratories Of Hawaii, LLP in its reading room, the most recent dated May 6, 2025. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Clinical Laboratories Of Hawaii, LLP?

The most recent FDA inspection on file ended Aug 21, 2025 at Honolulu, HI and was classified NAI. FDA has 17 inspections of Clinical Laboratories Of Hawaii, LLP on file.

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