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Luminis Health Anne Arundel Medical Center Blood Bank FDA Record

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

Latest inspection NAI · Aug 1, 2025
No warning letters matched by name

Inspections 8

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Luminis Health Anne Arundel Medical Center Blood Bank has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Luminis Health Anne Arundel Medical Center Blood Bank" is on file.

What these totals cover: FDA records filed under the name "Luminis Health Anne Arundel Medical Center Blood Bank".

Latest inspection: Aug 1, 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	8	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

Luminis Health Anne Arundel Medical Center Blood Bank's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Luminis Health Anne Arundel Medical Center Blood Bank: 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	1	0	0	0	0
2021	0	0	0	0	0
2020	1	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

8 inspections from Sep 3, 2010 to Aug 1, 2025.

Date	Site	Product	Classification	FEI
Aug 1, 2025	Annapolis, MD	Biologics	No Action Indicated (NAI)	1170453
Nov 17, 2022	Annapolis, MD	Biologics	No Action Indicated (NAI)	1170453
Feb 6, 2020	Annapolis, MD	Biologics	No Action Indicated (NAI)	1170453
Aug 31, 2018	Annapolis, MD	Biologics	No Action Indicated (NAI)	1170453
May 25, 2016	Annapolis, MD	Biologics	No Action Indicated (NAI)	1170453
Jun 19, 2014	Annapolis, MD	Biologics	No Action Indicated (NAI)	1170453
Mar 16, 2012	Annapolis, MD	Biologics	Voluntary Action Indicated (VAI)	1170453
Sep 3, 2010	Annapolis, MD	Biologics	No Action Indicated (NAI)	1170453

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 1170453	Annapolis, MD	8	Aug 1, 2025

Luminis Health Anne Arundel Medical Center Blood Bank and the FDA: common questions

Has Luminis Health Anne Arundel Medical Center Blood Bank received an FDA warning letter?

No FDA warning letter addressed to the name "Luminis Health Anne Arundel Medical Center Blood Bank" 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 Luminis Health Anne Arundel Medical Center Blood Bank received an FDA Form 483?

FDA has not published a Form 483 for "Luminis Health Anne Arundel Medical Center Blood Bank" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Luminis Health Anne Arundel Medical Center Blood Bank?

The most recent FDA inspection on file ended Aug 1, 2025 at Annapolis, MD and was classified NAI. FDA has 8 inspections of Luminis Health Anne Arundel Medical Center Blood Bank on file.

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