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American National Red Cross - Frederick Donor Center FDA Record

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

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

Inspections 9

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

American National Red Cross - Frederick Donor Center has 0 FDA recalls, 9 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "American National Red Cross - Frederick Donor Center" is on file.

What these totals cover: FDA records filed under the name "American National Red Cross - Frederick Donor Center".

Latest inspection: Mar 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	9	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

American National Red Cross - Frederick Donor Center's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

American National Red Cross - Frederick Donor 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	1	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	1	0	0	0	0
2018	0	0	0	0	0
2017	1	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

9 inspections from Feb 25, 2009 to Mar 14, 2025.

Date	Site	Product	Classification	FEI
Mar 14, 2025	Frederick, MD	Biologics	No Action Indicated (NAI)	1000142925
Jul 19, 2023	Frederick, MD	Biologics	No Action Indicated (NAI)	1000142925
Oct 23, 2019	Frederick, MD	Biologics	No Action Indicated (NAI)	1000142925
Dec 18, 2017	Frederick, MD	Biologics	No Action Indicated (NAI)	1000142925
Apr 27, 2016	Frederick, MD	Biologics	No Action Indicated (NAI)	1000142925
Jul 25, 2014	Frederick, MD	Biologics	No Action Indicated (NAI)	1000142925
Feb 24, 2012	Frederick, MD	Biologics	No Action Indicated (NAI)	1000142925
Jan 8, 2010	Frederick, MD	Biologics	No Action Indicated (NAI)	1000142925
Feb 25, 2009	Frederick, MD	Biologics	No Action Indicated (NAI)	1000142925

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 1000142925	Frederick, MD	9	Mar 14, 2025

American National Red Cross - Frederick Donor Center and the FDA: common questions

Has American National Red Cross - Frederick Donor Center received an FDA warning letter?

No FDA warning letter addressed to the name "American National Red Cross - Frederick Donor 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 American National Red Cross - Frederick Donor Center received an FDA Form 483?

FDA has not published a Form 483 for "American National Red Cross - Frederick Donor Center" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect American National Red Cross - Frederick Donor Center?

The most recent FDA inspection on file ended Mar 14, 2025 at Frederick, MD and was classified NAI. FDA has 9 inspections of American National Red Cross - Frederick Donor Center on file.

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