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Pacific Cancer Institute, Inc. FDA Record

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

Latest inspection NAI · May 14, 2025
No warning letters matched by name

Inspections 5

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Pacific Cancer Institute, Inc. has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Pacific Cancer Institute, Inc." is on file.

What these totals cover: FDA records filed under the name "Pacific Cancer Institute, Inc." and its spelling variant "Pacific Cancer Institute".

Latest inspection: May 14, 2025 · NAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	5	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

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

Pacific Cancer Institute, Inc.: 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

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

5 inspections from Aug 31, 2012 to May 14, 2025.

Date	Site	Product	Classification	FEI
May 14, 2025	Wailuku, HI	Biologics	No Action Indicated (NAI)	3007855961
May 1, 2018	Wailuku, HI	Biologics	No Action Indicated (NAI)	3007855961
Apr 7, 2016	Wailuku, HI	Biologics	No Action Indicated (NAI)	3007855961
Jul 16, 2014	Wailuku, HI	Biologics	No Action Indicated (NAI)	3007855961
Aug 31, 2012	Wailuku, HI	Biologics	No Action Indicated (NAI)	3007855961

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

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3007855961	Wailuku, HI	5	May 14, 2025

Pacific Cancer Institute, Inc. and the FDA: common questions

Has Pacific Cancer Institute, Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "Pacific Cancer Institute, Inc." 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 Pacific Cancer Institute, Inc. received an FDA Form 483?

FDA has not published a Form 483 for "Pacific Cancer Institute, Inc." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Pacific Cancer Institute, Inc.?

The most recent FDA inspection on file ended May 14, 2025 at Wailuku, HI and was classified NAI. FDA has 5 inspections of Pacific Cancer Institute, Inc. on file.

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