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American National Red Cross (The) FDA Inspection Record

FEI 2971430 · Inspections, Form 483s, warning letters and import refusals

American National Red Cross (The) is an FDA-inspected facility (FEI 2971430) located in San Leandro, CA, US. RegDataLab tracks 10 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Jul 18, 2019: No Action Indicated (NAI)
Inspections on record
10 (1 VAI, 9 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
48, latest Apr 26, 2024

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

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Jul 18, 2019No Action Indicated (NAI)No citations listed
Aug 15, 2017No Action Indicated (NAI)No citations listed
Sep 2, 2015No Action Indicated (NAI)No citations listed
Jul 30, 2014No Action Indicated (NAI)No citations listed
Aug 2, 2013No Action Indicated (NAI)No citations listed
Aug 21, 2012No Action Indicated (NAI)No citations listed
Aug 21, 2012No Action Indicated (NAI)No citations listed
Aug 10, 2011Voluntary Action Indicated (VAI)Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b))
Sep 30, 2010No Action Indicated (NAI)No citations listed
Aug 21, 2009No Action Indicated (NAI)No citations listed

Recalls

Showing the 10 most recent of 48 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.

DateClassRecallProduct and reason
Apr 26, 2024Class IIB-0009-2025Red Blood Cells, Leukocytes Reduced
Misbranded Leukoreduced Red Blood Cells were distributed.
Dec 14, 2023Class IIIB-0428-2025Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced
Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced, which were not stored under continuous agitation, were distributed.
Feb 20, 2023Class IIB-0410-2023Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced
Leukoreduced Apheresis Platelet product, PAS, in which platelet yield did not meet specifications, was distributed.
Sep 1, 2022Class IIIB-0061-2023Red Blood Cells, Leukocytes Reduced
Red Blood Cell product, for which a visual inspection was not performed or documented, was distributed.
Jan 21, 2022Class IIIB-0279-2022Red Blood Cells, Leukocytes Reduced
Red Blood Cell product, for which a visual inspection was not performed or documented, was distributed.
Aug 12, 2021Class IIB-0031-2022Apheresis Platelets, Platelet Additive Solution Added, Leukocytes Reduced
Leukoreduced Apheresis Platelets, Platelet Additive Solution Added, not tested for pH, were distributed.
Aug 11, 2021Class IIB-0024-2022Apheresis Platelets, Platelet Additive Solution Added, Leukocytes Reduced
Misbranded Plateletpheresis product was distributed.
Mar 16, 2020Class IIIB-0497-2020Red Blood Cells, Leukocytes Reduced
Misbranded Red Blood Cell product, was distributed.
Dec 31, 2019Class IIB-0400-2020Apheresis Platelets, Leukocytes Reduced, Irradiated and 1 more product
Blood products, which did not meet the acceptable product specifications for release, were distributed.
Nov 15, 2019Class IIB-0230-2020Apheresis Platelets, Leukocytes Reduced, Irradiated and 1 more product
Platelets, which was not tested for pH and platelet count, were distributed.

FDA record score

10 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.

33 records behind this number
RecordDatePoints x age weightAdds
Class II recall B-0009-2025, this FEI as the recalling firmApr 26, 20244 x 0.62.4
Class II recall B-0410-2023, this FEI as the recalling firmFeb 20, 20234 x 0.62.4
Class II recall B-0031-2022, this FEI as the recalling firmAug 12, 20214 x 0.251
Class II recall B-0024-2022, this FEI as the recalling firmAug 11, 20214 x 0.251
Class II recall B-0400-2020, this FEI as the recalling firmDec 31, 20194 x 0.251
Class II recall B-0230-2020, this FEI as the recalling firmNov 15, 20194 x 0.251
Class II recall B-0630-2018, this FEI as the recalling firmApr 10, 20184 x 0.251
Class II recall B-0103-2017, this FEI as the recalling firmAug 7, 201610 years or older, so it adds no points0
Class II recall B-0488-15, this FEI as the recalling firmJan 18, 201510 years or older, so it adds no points0
Class II recall B-0474-15, this FEI as the recalling firmJan 17, 201510 years or older, so it adds no points0
Class II recall B-0908-14, this FEI as the recalling firmMay 19, 201410 years or older, so it adds no points0
Class II recall B-0123-14, this FEI as the recalling firmSep 11, 201310 years or older, so it adds no points0
Class II recall B-0116-14, this FEI as the recalling firmAug 16, 201310 years or older, so it adds no points0
Class II recall B-1763-13, this FEI as the recalling firmApr 10, 201310 years or older, so it adds no points0
Inspection classified VAIAug 10, 201110 years or older, so it adds no points0
Class II recall B-0098-13, this FEI as the recalling firmJul 10, 200910 years or older, so it adds no points0
Class II recall B-1804-12, this FEI as the recalling firmOct 19, 200710 years or older, so it adds no points0
Class II recall B-2289-12, this FEI as the recalling firmOct 19, 200510 years or older, so it adds no points0
Class II recall B-1476-12, this FEI as the recalling firmSep 2, 200510 years or older, so it adds no points0
Class II recall B-1602-08, this FEI as the recalling firmJan 28, 200510 years or older, so it adds no points0
Class II recall B-1601-08, this FEI as the recalling firmJan 25, 200510 years or older, so it adds no points0
Class II recall B-1603-08, this FEI as the recalling firmDec 15, 200410 years or older, so it adds no points0
Class II recall B-0038-4, this FEI as the recalling firmSep 23, 200210 years or older, so it adds no points0
Class II recall B-0233-4, this FEI as the recalling firmMay 21, 200210 years or older, so it adds no points0
Class II recall B-0791-4, this FEI as the recalling firmApr 25, 200210 years or older, so it adds no points0
Class II recall B-0788-4, this FEI as the recalling firmMar 11, 200210 years or older, so it adds no points0
Class II recall B-0790-4, this FEI as the recalling firmMar 11, 200210 years or older, so it adds no points0
Class II recall B-0501-6, this FEI as the recalling firmDec 21, 200110 years or older, so it adds no points0
Class II recall B-0504-6, this FEI as the recalling firmAug 15, 200110 years or older, so it adds no points0
Class II recall B-1242-4, this FEI as the recalling firmJan 22, 200110 years or older, so it adds no points0
Class II recall B1245-4, this FEI as the recalling firmNov 6, 200010 years or older, so it adds no points0
Class II recall B-0817-3, this FEI as the recalling firmMay 23, 200010 years or older, so it adds no points0
Class II recall B-0712-3, this FEI as the recalling firmMar 27, 200010 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
American National Red Cross (The)
Location
San Leandro, CA (US)
Source
inspections

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.