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Blood Bank Of Hawaii FDA Record

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

Latest inspection NAI · Aug 20, 2025
No warning letters matched by name

Inspections 13

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Blood Bank Of Hawaii has 0 FDA recalls, 13 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Blood Bank Of Hawaii" is on file.

What these totals cover: FDA records filed under the name "Blood Bank Of Hawaii".

Latest inspection: Aug 20, 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	13	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

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

Blood Bank Of Hawaii: FDA inspections per year

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	2	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	2	0	0	0	0
2018	0	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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Recent FDA inspections

13 inspections from Jun 12, 2009 to Aug 20, 2025.

Date	Site	Product	Classification	FEI
Aug 20, 2025	Kapolei, HI	Biologics	No Action Indicated (NAI)	2971883
Aug 14, 2025	Honolulu, HI	Biologics	No Action Indicated (NAI)	2970043
May 28, 2019	Honolulu, HI	Biologics	No Action Indicated (NAI)	2970043
Mar 8, 2019	Kapolei, HI	Biologics	No Action Indicated (NAI)	2971883
Nov 3, 2016	Honolulu, HI	Biologics	No Action Indicated (NAI)	2970043
Oct 26, 2016	Kapolei, HI	Biologics	No Action Indicated (NAI)	2971883
Jun 25, 2015	Kapolei, HI	Biologics	No Action Indicated (NAI)	2971883
Apr 29, 2015	Honolulu, HI	Biologics	No Action Indicated (NAI)	2970043
Aug 21, 2013	Honolulu, HI	Biologics	No Action Indicated (NAI)	2970043
Jun 20, 2013	Kapolei, HI	Biologics	No Action Indicated (NAI)	2971883
Dec 14, 2010	Honolulu, HI	Biologics	No Action Indicated (NAI)	2970043
Aug 13, 2010	Kapolei, HI	Biologics	No Action Indicated (NAI)	2971883
Jun 12, 2009	Honolulu, HI	Biologics	No Action Indicated (NAI)	2970043

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

2 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 2971883	Kapolei, HI	6	Aug 20, 2025
FEI 2970043	Honolulu, HI	7	Aug 14, 2025

Blood Bank Of Hawaii and the FDA: common questions

Has Blood Bank Of Hawaii received an FDA warning letter?

No FDA warning letter addressed to the name "Blood Bank Of Hawaii" 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 Blood Bank Of Hawaii received an FDA Form 483?

FDA has not published a Form 483 for "Blood Bank Of Hawaii" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Blood Bank Of Hawaii?

The most recent FDA inspection on file ended Aug 20, 2025 at Kapolei, HI and was classified NAI. FDA has 13 inspections of Blood Bank Of Hawaii on file.

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