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American National Red Cross (The) Carolinas Region FDA Inspection Record

FEI 1073007 · Inspections, Form 483s, warning letters and import refusals

American National Red Cross (The) Carolinas Region is an FDA-inspected facility (FEI 1073007) located in Charlotte, NC, US. RegDataLab tracks 13 FDA inspections at this facility.

What FDA found at this site

Latest inspection: Mar 27, 2025: No Action Indicated (NAI)
Inspections on record: 13 (3 VAI, 10 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: 161, latest Feb 12, 2025

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 13 inspections. Citations are the inspector observations FDA publishes for the inspection.

Date	Result	What FDA cited
Mar 27, 2025	No Action Indicated (NAI)	No citations listed
Feb 1, 2023	No Action Indicated (NAI)	No citations listed
Apr 11, 2019	No Action Indicated (NAI)	No citations listed
Mar 10, 2017	No Action Indicated (NAI)	No citations listed
Jun 19, 2015	No Action Indicated (NAI)	No citations listed
Feb 20, 2015	No Action Indicated (NAI)	No citations listed
Jun 19, 2014	Voluntary Action Indicated (VAI)	Person performing, test results, interpretation (21 CFR 606.160(a)(1)) Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b)) Schedules and procedures for equipment & calibration (21 CFR 606.100(b)(15))
Aug 2, 2013	No Action Indicated (NAI)	No citations listed
Nov 14, 2012	No Action Indicated (NAI)	No citations listed
Aug 23, 2012	Voluntary Action Indicated (VAI)	Person performing, test results, interpretation (21 CFR 606.160(a)(1)) Following manufacturer's instructions (21 CFR 606.65(e)) Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b))

Recalls

Showing the 10 most recent of 161 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
Feb 12, 2025	Class III	B-0006-2026	Apheresis PF24RT24 Plasma Apheresis PF24RT24 Plasma, for which a visual inspection was not performed or documented, were distributed.
Nov 19, 2024	Class II	B-0252-2025	Red Blood Cells, Leukocytes Reduced Misbranded Leukoreduced Red Blood Cells were distributed.
Sep 3, 2021	Class II	B-0143-2022	Apheresis PF24 Plasma Blood product, which was not quarantined subsequent to receiving information regarding a post donation illness, was distributed.
Jun 5, 2021	Class III	B-0558-2021	Apheresis Platelets, Leukocytes Reduced Blood products, which did not meet acceptable product specifications, were distributed
Apr 30, 2021	Class II	B-0526-2021	Apheresis Platelets, Platelet Additive Solution Added, Leukocytes Reduced Plateletpheresis products, for which quality control for pH testing was not performed, were distributed.
Nov 18, 2020	Class II	B-0177-2021	Apheresis Platelets, Platelet Additive Solution Added, Leukocytes Reduced Plateletpheresis products, in which quality control for residual WBC count was not performed, were distributed.
Feb 13, 2020	Class II	B-0427-2020	Apheresis Platelets, Platelet Additive Solution Added, Leukocytes Reduced Plateletpheresis product, for which the pathogen reduction process was not performed in accordance with specifications, was distributed.
Jun 1, 2019	Class II	B-0837-2019	Blood and Blood Products for Reprocessing and 1 more product Blood products, for which donor eligibility screening was incorrectly performed, were distributed.
Oct 5, 2018	Class II	B-0174-2019	PF24 Plasma Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Apr 27, 2018	Class II	B-0655-2018	Red Blood Cells, Leukocytes Reduced and 1 more product Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.

FDA record score

18 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.

125 records behind this number

Record	Date	Points x age weight	Adds
Class II recall B-0252-2025, this FEI as the recalling firm	Nov 19, 2024	4 x 1	4
Class II recall B-0143-2022, this FEI as the recalling firm	Sep 3, 2021	4 x 0.25	1
Class II recall B-0526-2021, this FEI as the recalling firm	Apr 30, 2021	4 x 0.25	1
Class II recall B-0177-2021, this FEI as the recalling firm	Nov 18, 2020	4 x 0.25	1
Class II recall B-0427-2020, this FEI as the recalling firm	Feb 13, 2020	4 x 0.25	1
Class II recall B-0837-2019, this FEI as the recalling firm	Jun 1, 2019	4 x 0.25	1
Class II recall B-0174-2019, this FEI as the recalling firm	Oct 5, 2018	4 x 0.25	1
Class II recall B-0655-2018, this FEI as the recalling firm	Apr 27, 2018	4 x 0.25	1
Class II recall B-0557-2018, this FEI as the recalling firm	Mar 17, 2018	4 x 0.25	1
Class II recall B-0169-2018, this FEI as the recalling firm	Sep 24, 2017	4 x 0.25	1
Class II recall B-0044-2018, this FEI as the recalling firm	Aug 28, 2017	4 x 0.25	1
Class II recall B-0661-2017, this FEI as the recalling firm	Mar 24, 2017	4 x 0.25	1
Class II recall B-0575-2017, this FEI as the recalling firm	Mar 14, 2017	4 x 0.25	1
Class II recall B-0395-2017, this FEI as the recalling firm	Dec 16, 2016	4 x 0.25	1
Class II recall B-0401-2017, this FEI as the recalling firm	Dec 16, 2016	4 x 0.25	1
Inspection classified VAI	Jun 19, 2014	10 years or older, so it adds no points	0
Class II recall B-0326-14, this FEI as the recalling firm	Oct 18, 2013	10 years or older, so it adds no points	0
Class II recall B-0338-14, this FEI as the recalling firm	Sep 18, 2013	10 years or older, so it adds no points	0
Class II recall B-1637-13, this FEI as the recalling firm	Feb 11, 2013	10 years or older, so it adds no points	0
Class II recall B-1003-13, this FEI as the recalling firm	Dec 3, 2012	10 years or older, so it adds no points	0
Inspection classified VAI	Aug 23, 2012	10 years or older, so it adds no points	0
Class II recall B-1767-12, this FEI as the recalling firm	Apr 13, 2012	10 years or older, so it adds no points	0
Class II recall B-1713-13, this FEI as the recalling firm	Jan 27, 2011	10 years or older, so it adds no points	0
Inspection classified VAI	Jul 21, 2010	10 years or older, so it adds no points	0
Class II recall B-0822-15, this FEI as the recalling firm	Jun 30, 2010	10 years or older, so it adds no points	0
Class II recall B-0421-15, this FEI as the recalling firm	Jun 26, 2010	10 years or older, so it adds no points	0
Class II recall B-1613-09, this FEI as the recalling firm	Mar 14, 2008	10 years or older, so it adds no points	0
Class II recall B-1476-08, this FEI as the recalling firm	Dec 16, 2007	10 years or older, so it adds no points	0
Class II recall B-1471-08, this FEI as the recalling firm	Dec 13, 2007	10 years or older, so it adds no points	0
Class II recall B-1479-08, this FEI as the recalling firm	Dec 5, 2007	10 years or older, so it adds no points	0
Class II recall B-0697-08, this FEI as the recalling firm	Sep 20, 2007	10 years or older, so it adds no points	0
Class II recall B-0699-08, this FEI as the recalling firm	Aug 9, 2007	10 years or older, so it adds no points	0
Class II recall B-2570-10, this FEI as the recalling firm	Aug 1, 2007	10 years or older, so it adds no points	0
Class II recall B-0304-08, this FEI as the recalling firm	Jul 28, 2007	10 years or older, so it adds no points	0
Class II recall B-0321-08, this FEI as the recalling firm	Jul 27, 2007	10 years or older, so it adds no points	0
Class II recall B-1088-08, this FEI as the recalling firm	Jul 19, 2007	10 years or older, so it adds no points	0
Class II recall B-0332-08, this FEI as the recalling firm	Jul 13, 2007	10 years or older, so it adds no points	0
Class II recall B-0330-08, this FEI as the recalling firm	Jul 6, 2007	10 years or older, so it adds no points	0
Class II recall B-0696-08, this FEI as the recalling firm	May 23, 2007	10 years or older, so it adds no points	0
Class II recall B-0063-08, this FEI as the recalling firm	Apr 30, 2007	10 years or older, so it adds no points	0
Class II recall B-0319-08, this FEI as the recalling firm	Apr 5, 2007	10 years or older, so it adds no points	0
Class II recall B-0326-08, this FEI as the recalling firm	Apr 5, 2007	10 years or older, so it adds no points	0
Class II recall B-0082-08, this FEI as the recalling firm	Feb 4, 2007	10 years or older, so it adds no points	0
Class II recall B-0061-08, this FEI as the recalling firm	Jan 26, 2007	10 years or older, so it adds no points	0
Class II recall B-0715-08, this FEI as the recalling firm	Nov 21, 2006	10 years or older, so it adds no points	0
Class II recall B-0113-08, this FEI as the recalling firm	Nov 2, 2006	10 years or older, so it adds no points	0
Class II recall B-0135-08, this FEI as the recalling firm	Apr 10, 2006	10 years or older, so it adds no points	0
Class II recall B-0420-08, this FEI as the recalling firm	Jan 26, 2006	10 years or older, so it adds no points	0
Class II recall B1284-6, this FEI as the recalling firm	Oct 6, 2005	10 years or older, so it adds no points	0
Class II recall B-0393-7, this FEI as the recalling firm	Oct 5, 2005	10 years or older, so it adds no points	0
Class II recall B-1089-6, this FEI as the recalling firm	Aug 4, 2005	10 years or older, so it adds no points	0
Class II recall B-0766-6, this FEI as the recalling firm	Jun 21, 2005	10 years or older, so it adds no points	0
Class II recall B-0948-6, this FEI as the recalling firm	Jun 14, 2005	10 years or older, so it adds no points	0
Class II recall B-0934-6, this FEI as the recalling firm	Jun 1, 2005	10 years or older, so it adds no points	0
Class II recall B-0964-6, this FEI as the recalling firm	Jun 1, 2005	10 years or older, so it adds no points	0
Class II recall B-0452-6, this FEI as the recalling firm	May 18, 2005	10 years or older, so it adds no points	0
Class II recall B-0920-6, this FEI as the recalling firm	May 11, 2005	10 years or older, so it adds no points	0
Class II recall B-0415-6, this FEI as the recalling firm	Apr 19, 2005	10 years or older, so it adds no points	0
Class II recall B-1325-6, this FEI as the recalling firm	Mar 15, 2005	10 years or older, so it adds no points	0
Class II recall B-1928-5, this FEI as the recalling firm	Mar 6, 2005	10 years or older, so it adds no points	0
Class II recall B-2026-5, this FEI as the recalling firm	Feb 25, 2005	10 years or older, so it adds no points	0
Class II recall B-0994-5, this FEI as the recalling firm	Dec 17, 2004	10 years or older, so it adds no points	0
Class II recall B-0999-5, this FEI as the recalling firm	Dec 14, 2004	10 years or older, so it adds no points	0
Class II recall B-0738-6, this FEI as the recalling firm	Oct 20, 2004	10 years or older, so it adds no points	0
Class II recall B-0175-6, this FEI as the recalling firm	Sep 30, 2004	10 years or older, so it adds no points	0
Class II recall B-2384-5, this FEI as the recalling firm	Sep 22, 2004	10 years or older, so it adds no points	0
Class II recall B-0885-6, this FEI as the recalling firm	Sep 13, 2004	10 years or older, so it adds no points	0
Class II recall B-0860-6, this FEI as the recalling firm	Aug 30, 2004	10 years or older, so it adds no points	0
Class II recall B-0863-6, this FEI as the recalling firm	Aug 27, 2004	10 years or older, so it adds no points	0
Class II recall B-0716-6, this FEI as the recalling firm	Aug 19, 2004	10 years or older, so it adds no points	0
Class II recall B-1019-5, this FEI as the recalling firm	Jul 24, 2004	10 years or older, so it adds no points	0
Class II recall B-0887-6, this FEI as the recalling firm	Jul 12, 2004	10 years or older, so it adds no points	0
Class II recall B-0888-6, this FEI as the recalling firm	Jun 17, 2004	10 years or older, so it adds no points	0
Class II recall B-0929-6, this FEI as the recalling firm	May 3, 2004	10 years or older, so it adds no points	0
Class II recall B-0931-6, this FEI as the recalling firm	Apr 29, 2004	10 years or older, so it adds no points	0
Class II recall B-2380-5, this FEI as the recalling firm	Apr 10, 2004	10 years or older, so it adds no points	0
Class II recall B-2382-5, this FEI as the recalling firm	Apr 9, 2004	10 years or older, so it adds no points	0
Class II recall B-0715-6, this FEI as the recalling firm	Apr 6, 2004	10 years or older, so it adds no points	0
Class II recall B-0962-6, this FEI as the recalling firm	Mar 27, 2004	10 years or older, so it adds no points	0
Class II recall B-0867-6, this FEI as the recalling firm	Mar 19, 2004	10 years or older, so it adds no points	0
Class II recall B-1953-5, this FEI as the recalling firm	Mar 8, 2004	10 years or older, so it adds no points	0
Class II recall B-0955-6, this FEI as the recalling firm	Feb 26, 2004	10 years or older, so it adds no points	0
Class II recall B-0934-5, this FEI as the recalling firm	Feb 18, 2004	10 years or older, so it adds no points	0
Class II recall B-0928-5, this FEI as the recalling firm	Feb 17, 2004	10 years or older, so it adds no points	0
Class II recall B-0933-5, this FEI as the recalling firm	Feb 17, 2004	10 years or older, so it adds no points	0
Class II recall B-0938-5, this FEI as the recalling firm	Feb 4, 2004	10 years or older, so it adds no points	0
Class II recall B-1032-6, this FEI as the recalling firm	Jan 24, 2004	10 years or older, so it adds no points	0
Class II recall B-0832-5, this FEI as the recalling firm	Jan 9, 2004	10 years or older, so it adds no points	0
Class II recall B-1028-5, this FEI as the recalling firm	Nov 17, 2003	10 years or older, so it adds no points	0
Class II recall B-0078-6, this FEI as the recalling firm	Oct 10, 2003	10 years or older, so it adds no points	0
Class II recall B-1003-5, this FEI as the recalling firm	Oct 1, 2003	10 years or older, so it adds no points	0
Class II recall B-0948-5, this FEI as the recalling firm	Sep 8, 2003	10 years or older, so it adds no points	0
Class II recall B-1201-5, this FEI as the recalling firm	Sep 2, 2003	10 years or older, so it adds no points	0
Class II recall B-1927-5, this FEI as the recalling firm	Jul 10, 2003	10 years or older, so it adds no points	0
Class II recall B-2381-5, this FEI as the recalling firm	Jun 20, 2003	10 years or older, so it adds no points	0
Class II recall B-0800-4, this FEI as the recalling firm	Jun 2, 2003	10 years or older, so it adds no points	0
Class II recall B-1790-4, this FEI as the recalling firm	May 30, 2003	10 years or older, so it adds no points	0
Class II recall B-0530-4, this FEI as the recalling firm	May 6, 2003	10 years or older, so it adds no points	0
Class II recall B-0501-4, this FEI as the recalling firm	Apr 9, 2003	10 years or older, so it adds no points	0
Class II recall B-1771-4, this FEI as the recalling firm	Apr 9, 2003	10 years or older, so it adds no points	0
Class II recall B-0577-4, this FEI as the recalling firm	Apr 1, 2003	10 years or older, so it adds no points	0
Class II recall B-0576-4, this FEI as the recalling firm	Mar 13, 2003	10 years or older, so it adds no points	0
Class II recall B-1841-4, this FEI as the recalling firm	Feb 6, 2003	10 years or older, so it adds no points	0
Class II recall B-1096-3, this FEI as the recalling firm	Jan 3, 2003	10 years or older, so it adds no points	0
Class II recall B-0530-6, this FEI as the recalling firm	Dec 19, 2002	10 years or older, so it adds no points	0
Class II recall B-1033-3, this FEI as the recalling firm	Dec 9, 2002	10 years or older, so it adds no points	0
Class II recall B-1056-3, this FEI as the recalling firm	Nov 27, 2002	10 years or older, so it adds no points	0
Class II recall B-0530-3, this FEI as the recalling firm	Sep 24, 2002	10 years or older, so it adds no points	0
Class II recall B-0835-3, this FEI as the recalling firm	Aug 23, 2002	10 years or older, so it adds no points	0
Class II recall B-0622-3, this FEI as the recalling firm	Aug 21, 2002	10 years or older, so it adds no points	0
Class II recall B-0646-3, this FEI as the recalling firm	Aug 20, 2002	10 years or older, so it adds no points	0
Class II recall B-1215-6, this FEI as the recalling firm	Aug 6, 2002	10 years or older, so it adds no points	0
Class II recall B-0746-3, this FEI as the recalling firm	Jul 29, 2002	10 years or older, so it adds no points	0
Class II recall B-1103-6, this FEI as the recalling firm	Apr 19, 2002	10 years or older, so it adds no points	0
Class II recall B-0663-3, this FEI as the recalling firm	Feb 5, 2002	10 years or older, so it adds no points	0
Class II recall B-0634-3, this FEI as the recalling firm	Jan 31, 2002	10 years or older, so it adds no points	0
Class II recall B-0675-3, this FEI as the recalling firm	Jan 30, 2002	10 years or older, so it adds no points	0
Class II recall B-1344-6, this FEI as the recalling firm	Dec 20, 2001	10 years or older, so it adds no points	0
Class II recall B-1288-6, this FEI as the recalling firm	Nov 29, 2001	10 years or older, so it adds no points	0
Class II recall B-0618-3, this FEI as the recalling firm	Jul 31, 2001	10 years or older, so it adds no points	0
Class II recall B-1026-4, this FEI as the recalling firm	Apr 12, 2001	10 years or older, so it adds no points	0
Class II recall B-1027-4, this FEI as the recalling firm	Mar 27, 2001	10 years or older, so it adds no points	0
Class II recall B-1028-4, this FEI as the recalling firm	Oct 26, 2000	10 years or older, so it adds no points	0
Class II recall B-0725-6, this FEI as the recalling firm	Jul 28, 2000	10 years or older, so it adds no points	0
Class II recall B-1674-6, this FEI as the recalling firm	Jun 5, 2000	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) Carolinas Region
Location: Charlotte, NC (US)
Source: inspections