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American National Red Cross (The) FDA Inspection Record

FEI 2573018 · Inspections, Form 483s, warning letters and import refusals

American National Red Cross (The) is an FDA-inspected facility (FEI 2573018) located in Hanover Township, PA, US. RegDataLab tracks 14 FDA inspections at this facility.

What FDA found at this site

Latest inspection: Sep 22, 2026: No Action Indicated (NAI)
Inspections on record: 14 (1 VAI, 13 NAI)
Last OAI inspection: None on record
Warning letters: None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Recalls as the recalling firm: 45, latest Jun 8, 2019

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Showing the 10 most recent of 14 inspections. Citations are the inspector observations FDA publishes for the inspection.

Date	Result	What FDA cited
Sep 22, 2026	No Action Indicated (NAI)	No citations listed
Aug 19, 2022	No Action Indicated (NAI)	No citations listed
Oct 30, 2018	No Action Indicated (NAI)	No citations listed
Oct 12, 2016	No Action Indicated (NAI)	No citations listed
Jan 9, 2015	No Action Indicated (NAI)	No citations listed
Dec 31, 2013	No Action Indicated (NAI)	No citations listed
Nov 21, 2013	No Action Indicated (NAI)	No citations listed
Nov 12, 2013	No Action Indicated (NAI)	No citations listed
Oct 2, 2012	Voluntary Action Indicated (VAI)	Calibration/Inspection/Checking not done (21 CFR 211.68(a))
Jun 19, 2012	No Action Indicated (NAI)	No citations listed

Recalls

Showing the 10 most recent of 45 recalls. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

Date	Class	Recall	Product and reason
Jun 8, 2019	Class III	B-0853-2019	Blood and Blood Products for Reprocessing Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
May 7, 2019	Class II	B-0747-2019	PF24 Plasma Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Feb 24, 2015	Class II	B-0541-15	Red Blood Cells Leukocytes Reduced Blood product in which routine testing/testing performed, interpreted, or documented incorrectly, was distributed.
Mar 11, 2014	Class III	B-0613-14	Red Blood Cells Leukocytes Reduced Irradiated Blood products, labeled with extended expiration dates following irradiation, were distributed.
Oct 9, 2013	Class III	B-0171-14	Blood and Blood Products for Reprocessing Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Oct 29, 2010	Class II	B-1748-13	Red Blood Cells Leukocytes Reduced and 2 more products Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Apr 29, 2008	Class II	B-1677-08	Recovered Plasma and 1 more product Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Apr 22, 2008	Class II	B-1627-08	Recovered Plasma Frozen and 1 more product Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed
Apr 21, 2008	Class II	B-1625-08	Red Blood Cells Leukocytes Reduced and 1 more product Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Jan 24, 2008	Class II	B-1431-08	Recovered Plasma Frozen and 1 more product Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.

FDA record score

1 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 14, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

34 records behind this number

Record	Date	Points x age weight	Adds
Class II recall B-0747-2019, this FEI as the recalling firm	May 7, 2019	4 x 0.25	1
Class II recall B-0541-15, this FEI as the recalling firm	Feb 24, 2015	10 years or older, so it adds no points	0
Inspection classified VAI	Oct 2, 2012	10 years or older, so it adds no points	0
Class II recall B-1748-13, this FEI as the recalling firm	Oct 29, 2010	10 years or older, so it adds no points	0
Class II recall B-1677-08, this FEI as the recalling firm	Apr 29, 2008	10 years or older, so it adds no points	0
Class II recall B-1627-08, this FEI as the recalling firm	Apr 22, 2008	10 years or older, so it adds no points	0
Class II recall B-1625-08, this FEI as the recalling firm	Apr 21, 2008	10 years or older, so it adds no points	0
Class II recall B-1431-08, this FEI as the recalling firm	Jan 24, 2008	10 years or older, so it adds no points	0
Class II recall B-1488-08, this FEI as the recalling firm	Jan 7, 2008	10 years or older, so it adds no points	0
Class II recall B-1091-08, this FEI as the recalling firm	Nov 16, 2007	10 years or older, so it adds no points	0
Class II recall B-0247-08, this FEI as the recalling firm	Sep 7, 2007	10 years or older, so it adds no points	0
Class II recall B-0004-08, this FEI as the recalling firm	May 24, 2007	10 years or older, so it adds no points	0
Class II recall B-0129-08, this FEI as the recalling firm	May 3, 2007	10 years or older, so it adds no points	0
Class II recall B-1332-07, this FEI as the recalling firm	Dec 21, 2006	10 years or older, so it adds no points	0
Class II recall B-1320-07, this FEI as the recalling firm	Nov 10, 2006	10 years or older, so it adds no points	0
Class II recall B-1700-6, this FEI as the recalling firm	Mar 30, 2006	10 years or older, so it adds no points	0
Class II recall B-0233-6, this FEI as the recalling firm	Jul 21, 2005	10 years or older, so it adds no points	0
Class II recall B-2375-5, this FEI as the recalling firm	May 26, 2005	10 years or older, so it adds no points	0
Class II recall B-1852-5, this FEI as the recalling firm	Apr 21, 2005	10 years or older, so it adds no points	0
Class II recall B-1853-5, this FEI as the recalling firm	Apr 13, 2005	10 years or older, so it adds no points	0
Class II recall B-0656-5, this FEI as the recalling firm	Oct 5, 2004	10 years or older, so it adds no points	0
Class II recall B-0671-5, this FEI as the recalling firm	Oct 5, 2004	10 years or older, so it adds no points	0
Class II recall B-0069-5, this FEI as the recalling firm	Jul 29, 2004	10 years or older, so it adds no points	0
Class II recall B-1921-4, this FEI as the recalling firm	Jun 5, 2004	10 years or older, so it adds no points	0
Class II recall B-1922-4, this FEI as the recalling firm	May 6, 2004	10 years or older, so it adds no points	0
Class II recall B-1700-3, this FEI as the recalling firm	May 7, 2003	10 years or older, so it adds no points	0
Class II recall B-1768-3, this FEI as the recalling firm	Apr 2, 2003	10 years or older, so it adds no points	0
Class II recall B-1424-3, this FEI as the recalling firm	Mar 7, 2003	10 years or older, so it adds no points	0
Class II recall B-1425-3, this FEI as the recalling firm	Feb 15, 2003	10 years or older, so it adds no points	0
Class II recall B-0933-3, this FEI as the recalling firm	Nov 6, 2002	10 years or older, so it adds no points	0
Class II recall B-0935-3, this FEI as the recalling firm	Oct 23, 2002	10 years or older, so it adds no points	0
Class II recall B-0939-3, this FEI as the recalling firm	Oct 2, 2002	10 years or older, so it adds no points	0
Class II recall B-0913-3, this FEI as the recalling firm	Aug 27, 2002	10 years or older, so it adds no points	0
Class II recall B-0919-3, this FEI as the recalling firm	Mar 21, 2002	10 years or older, so it adds no points	0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
Records	Last refreshed	Source as of	Status
Inspections	Nov 14, 2026	Newest record Nov 5, 2026	Current
Inspection citations	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions (warning letters, injunctions and other action types)	Nov 2, 2026	Newest record Oct 29, 2026	Current
Warning letter text	Nov 14, 2026	Newest record Nov 10, 2026	Current
Recalls (Enforcement Report)	Nov 14, 2026	Newest record Nov 11, 2026	Current
Form 483s and inspection documents	Nov 13, 2026	Newest record Nov 12, 2026	Current
Import refusals	Nov 2, 2026	Newest record Oct 22, 2026	Current

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Facility details

Company: American National Red Cross (The)
Location: Hanover Township, PA (US)
Source: inspections