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American National Red Cross (The) FDA Inspection Record

FEI 2972991 · Inspections, Form 483s, warning letters and import refusals

American National Red Cross (The) is an FDA-inspected facility (FEI 2972991) located in San Jose, CA, US. RegDataLab tracks 8 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Dec 13, 2022: No Action Indicated (NAI)
Inspections on record
8 (2 VAI, 6 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
Form 483 and inspection documents
1 in FDA's reading room
Recalls as the recalling firm
3, latest Feb 24, 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

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

DateResultWhat FDA cited
Dec 13, 2022No Action Indicated (NAI)No citations listed
Sep 18, 2017No Action Indicated (NAI)No citations listed
Mar 23, 2015No Action Indicated (NAI)No citations listed
Apr 11, 2014No Action Indicated (NAI)No citations listed
Jul 15, 2013Voluntary Action Indicated (VAI)Divided manufacturing (21 CFR 610.63)
Jun 28, 2012No Action Indicated (NAI)No citations listed
Sep 13, 2010Voluntary Action Indicated (VAI)Required records (21 CFR 606.160(b))
Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b))
Jul 14, 2009No Action Indicated (NAI)No citations listed

Recalls

Newest first. 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
Feb 24, 2025Class IIIB-0048-2026Apheresis Red Blood Cells, Leukocytes Reduced
Apheresis Red Blood Cells, Leukocytes Reduced, for which a visual inspection was not performed or documented, were distributed.
Apr 29, 2022Class IIIB-0020-2023Red Blood Cells, Leukocytes Reduced
Leukoreduced Red Blood Cells were distributed without a final visual check.
Nov 9, 2019Class IIB-0304-2020Apheresis Fresh Frozen Plasma
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.

Form 483s and inspection documents

  • 483 on FDA.gov
    FDA listing date Jul 11, 2015, which is not always the inspection or issue date. Published by FDA Jan 18, 2024.

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.

3 records behind this number
RecordDatePoints x age weightAdds
Class II recall B-0304-2020, this FEI as the recalling firmNov 9, 20194 x 0.251
Inspection classified VAIJul 15, 201310 years or older, so it adds no points0
Inspection classified VAISep 13, 201010 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 Jose, CA (US)
Source
inspections

FDA data resources

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