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American National Red Cross (The) FDA Inspection Record

FEI 3002957282 · Inspections, Form 483s, warning letters and import refusals

American National Red Cross (The) is an FDA-inspected facility (FEI 3002957282) located in West Henrietta, NY, US. RegDataLab tracks 7 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Aug 1, 2024: No Action Indicated (NAI)
Inspections on record
7 (1 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
128, latest Aug 15, 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
Aug 1, 2024No Action Indicated (NAI)No citations listed
Sep 13, 2019No Action Indicated (NAI)No citations listed
Oct 20, 2016No Action Indicated (NAI)No citations listed
Sep 13, 2013Voluntary Action Indicated (VAI)Clean & orderly (21 CFR 606.40)
Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b))
Oct 16, 2012No Action Indicated (NAI)No citations listed
Oct 13, 2010No Action Indicated (NAI)No citations listed
Jun 19, 2009No Action Indicated (NAI)No citations listed

Recalls

Showing the 10 most recent of 128 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
Aug 15, 2025Class IIB-0177-2026Red Blood Cells, Leukocytes Reduced, Irradiated and 2 more products
Red Blood Cells, Leukocytes Reduced, Irradiated, collected in a manner that compromises the sterility of the collection system, were…
Dec 21, 2024Class IIIB-0260-2025Whole Blood, Leukocytes Reduced and 2 more products
Whole Blood, Leukocytes Reduced, collected from a donor whose arm inspection was not properly performed, were distributed.
Sep 23, 2024Class IIB-0250-2025Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced
Leukoreduced, Apheresis Platelets, PAS, Pathogen Reduced product for which platelet yield did not meet specifications, was distributed.
Sep 13, 2024Class IIB-0218-2025Apheresis Red Blood Cells, Leukocytes Reduced
Apheresis Red Blood Cells, Leukocytes Reduced, collected in a manner with a potential for air contamination, were distributed.
Sep 3, 2024Class IIIB-0231-2026Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced
Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced, which lacked documentation of time exposed to the Compound Absorption Device…
Aug 29, 2024Class IIB-0381-2025Red Blood Cells, Leukocytes Reduced
Red Blood Cells, Leukocytes Reduced, which tested non-reactive for anti-HCV, but were collected from a donor who previously tested…
May 29, 2024Class IIB-0027-2025Apheresis Red Blood Cells, Leukocytes Reduced
Apheresis Red Blood Cells Product, which was labeled as leukocytes reduced but was not tested to verify white blood cell count, was…
May 29, 2024Class IIB-0373-2025PF24 Plasma and 1 more product
PF24 Plasma, collected in a manner that compromises the sterility of the collection system, were distributed.
Mar 8, 2024Class IIB-0061-2026Cryoprecipitated AHF and 1 more product
Cryoprecipitated AHF, that failed to meet the minimum specifications for fibrinogen levels, were distributed.
May 15, 2023Class IIB-0577-2023Whole Blood, Leukocytes Reduced
Whole Blood, Leukocytes Reduced, collected in a manner that compromises the sterility of the collection system, was distributed.

Form 483s and inspection documents

  • 483 on FDA.gov
    FDA listing date Jul 23, 2015, which is not always the inspection or issue date. Published by FDA Jan 18, 2024.

FDA record score

40 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.

92 records behind this number
RecordDatePoints x age weightAdds
Class II recall B-0177-2026, this FEI as the recalling firmAug 15, 20254 x 14
Class II recall B-0250-2025, this FEI as the recalling firmSep 23, 20244 x 0.62.4
Class II recall B-0218-2025, this FEI as the recalling firmSep 13, 20244 x 0.62.4
Class II recall B-0381-2025, this FEI as the recalling firmAug 29, 20244 x 0.62.4
Class II recall B-0027-2025, this FEI as the recalling firmMay 29, 20244 x 0.62.4
Class II recall B-0373-2025, this FEI as the recalling firmMay 29, 20244 x 0.62.4
Class II recall B-0061-2026, this FEI as the recalling firmMar 8, 20244 x 0.62.4
Class II recall B-0577-2023, this FEI as the recalling firmMay 15, 20234 x 0.62.4
Class II recall B-0405-2023, this FEI as the recalling firmDec 7, 20224 x 0.62.4
Class II recall B-0384-2023, this FEI as the recalling firmDec 1, 20224 x 0.62.4
Class II recall B-0155-2023, this FEI as the recalling firmJun 24, 20224 x 0.62.4
Class II recall B-0559-2023, this FEI as the recalling firmMay 13, 20224 x 0.62.4
Class II recall B-0030-2022, this FEI as the recalling firmAug 11, 20214 x 0.251
Class II recall B-0147-2022, this FEI as the recalling firmJul 17, 20214 x 0.251
Class II recall B-0082-2021, this FEI as the recalling firmAug 21, 20204 x 0.251
Class II recall B-0061-2021, this FEI as the recalling firmJun 13, 20204 x 0.251
Class II recall B-0299-2020, this FEI as the recalling firmDec 5, 20194 x 0.251
Class II recall B-0775-2018, this FEI as the recalling firmJun 7, 20184 x 0.251
Class II recall B-0401-2018, this FEI as the recalling firmNov 22, 20174 x 0.251
Class II recall B-0713-2017, this FEI as the recalling firmJun 12, 20174 x 0.251
Class II recall B-0324-2017, this FEI as the recalling firmDec 19, 20164 x 0.251
Class II recall B-0473-2017, this FEI as the recalling firmDec 12, 20164 x 0.251
Class II recall B-0188-2017, this FEI as the recalling firmSep 26, 201610 years or older, so it adds no points0
Class II recall B-0582-16, this FEI as the recalling firmApr 26, 201610 years or older, so it adds no points0
Class II recall B-0950-15, this FEI as the recalling firmJun 5, 201510 years or older, so it adds no points0
Inspection classified VAISep 13, 201310 years or older, so it adds no points0
Class II recall B-1879-13, this FEI as the recalling firmMar 22, 201310 years or older, so it adds no points0
Class II recall B-2362-13, this FEI as the recalling firmJun 26, 200910 years or older, so it adds no points0
Class II recall B-1728-13, this FEI as the recalling firmNov 4, 200810 years or older, so it adds no points0
Class II recall B-1627-13, this FEI as the recalling firmOct 30, 200810 years or older, so it adds no points0
Class II recall B-0905-13, this FEI as the recalling firmSep 23, 200810 years or older, so it adds no points0
Class II recall B-1024-13, this FEI as the recalling firmSep 4, 200810 years or older, so it adds no points0
Class II recall B-1322-13, this FEI as the recalling firmAug 21, 200810 years or older, so it adds no points0
Class II recall B-1325-13, this FEI as the recalling firmAug 8, 200810 years or older, so it adds no points0
Class II recall B-1663-13, this FEI as the recalling firmMay 27, 200810 years or older, so it adds no points0
Class II recall B-1290-13, this FEI as the recalling firmApr 9, 200810 years or older, so it adds no points0
Class II recall B-1650-13, this FEI as the recalling firmMar 25, 200810 years or older, so it adds no points0
Class II recall B-1326-13, this FEI as the recalling firmFeb 5, 200810 years or older, so it adds no points0
Class II recall B-0834-13, this FEI as the recalling firmNov 7, 200710 years or older, so it adds no points0
Class II recall B-1738-13, this FEI as the recalling firmOct 23, 200710 years or older, so it adds no points0
Class II recall B-1200-13, this FEI as the recalling firmOct 4, 200710 years or older, so it adds no points0
Class II recall B-0839-13, this FEI as the recalling firmAug 1, 200710 years or older, so it adds no points0
Class II recall B-1337-13, this FEI as the recalling firmJun 18, 200710 years or older, so it adds no points0
Class II recall B-1310-13, this FEI as the recalling firmApr 26, 200710 years or older, so it adds no points0
Class II recall B-0737-13, this FEI as the recalling firmJan 29, 200710 years or older, so it adds no points0
Class II recall B-0611-13, this FEI as the recalling firmDec 27, 200610 years or older, so it adds no points0
Class II recall B-1460-13, this FEI as the recalling firmDec 20, 200610 years or older, so it adds no points0
Class II recall B-0798-13, this FEI as the recalling firmDec 15, 200610 years or older, so it adds no points0
Class II recall B-1142-13, this FEI as the recalling firmDec 12, 200610 years or older, so it adds no points0
Class II recall B-1722-13, this FEI as the recalling firmDec 12, 200610 years or older, so it adds no points0
Class II recall B-0741-13, this FEI as the recalling firmAug 17, 200610 years or older, so it adds no points0
Class II recall B-0041-13, this FEI as the recalling firmAug 8, 200610 years or older, so it adds no points0
Class II recall B-0013-13, this FEI as the recalling firmMay 30, 200610 years or older, so it adds no points0
Class II recall B-1715-13, this FEI as the recalling firmMay 18, 200610 years or older, so it adds no points0
Class II recall B-0235-13, this FEI as the recalling firmDec 8, 200510 years or older, so it adds no points0
Class II recall B-2552-12, this FEI as the recalling firmAug 31, 200510 years or older, so it adds no points0
Class II recall B-0568-13, this FEI as the recalling firmAug 12, 200510 years or older, so it adds no points0
Class II recall B-2253-5, this FEI as the recalling firmAug 11, 200410 years or older, so it adds no points0
Class II recall B-0075-6, this FEI as the recalling firmJul 7, 200410 years or older, so it adds no points0
Class II recall B-0230-6, this FEI as the recalling firmJun 15, 200410 years or older, so it adds no points0
Class II recall B-0299-6, this FEI as the recalling firmJun 15, 200410 years or older, so it adds no points0
Class II recall B-0303-6, this FEI as the recalling firmMay 20, 200410 years or older, so it adds no points0
Class II recall B-1790-5, this FEI as the recalling firmMar 18, 200410 years or older, so it adds no points0
Class II recall B-1216-5, this FEI as the recalling firmMar 8, 200410 years or older, so it adds no points0
Class II recall B-0565-5, this FEI as the recalling firmFeb 13, 200410 years or older, so it adds no points0
Class II recall B-0625-5, this FEI as the recalling firmJan 26, 200410 years or older, so it adds no points0
Class II recall B-1217-5, this FEI as the recalling firmJan 9, 200410 years or older, so it adds no points0
Class II recall B-0329-5, this FEI as the recalling firmNov 13, 200310 years or older, so it adds no points0
Class II recall B-0328-5, this FEI as the recalling firmNov 6, 200310 years or older, so it adds no points0
Class II recall B-0190-5, this FEI as the recalling firmNov 5, 200310 years or older, so it adds no points0
Class II recall B-1838-4, this FEI as the recalling firmAug 25, 200310 years or older, so it adds no points0
Class II recall B-1726-4, this FEI as the recalling firmAug 5, 200310 years or older, so it adds no points0
Class II recall B-0428-4, this FEI as the recalling firmJul 17, 200310 years or older, so it adds no points0
Class II recall B-1762-4, this FEI as the recalling firmJun 27, 200310 years or older, so it adds no points0
Class II recall B-1295-4, this FEI as the recalling firmJun 24, 200310 years or older, so it adds no points0
Class II recall B-1308-4, this FEI as the recalling firmApr 8, 200310 years or older, so it adds no points0
Class II recall B-1048-4, this FEI as the recalling firmMar 19, 200310 years or older, so it adds no points0
Class II recall B-0522-4, this FEI as the recalling firmFeb 4, 200310 years or older, so it adds no points0
Class II recall B-0257-4, this FEI as the recalling firmJan 17, 200310 years or older, so it adds no points0
Class II recall B-1588-3, this FEI as the recalling firmDec 5, 200210 years or older, so it adds no points0
Class II recall B-1476-3, this FEI as the recalling firmNov 20, 200210 years or older, so it adds no points0
Class II recall B-1480-3, this FEI as the recalling firmOct 24, 200210 years or older, so it adds no points0
Class II recall B-1137-3, this FEI as the recalling firmSep 17, 200210 years or older, so it adds no points0
Class II recall B-298-3, this FEI as the recalling firmAug 27, 200210 years or older, so it adds no points0
Class II recall B-0984-3, this FEI as the recalling firmAug 19, 200210 years or older, so it adds no points0
Class II recall B-0985-3, this FEI as the recalling firmAug 16, 200210 years or older, so it adds no points0
Class II recall B-1551-5, this FEI as the recalling firmJun 24, 200210 years or older, so it adds no points0
Class II recall B-0764-3, this FEI as the recalling firmJun 18, 200210 years or older, so it adds no points0
Class II recall B-0766-3, this FEI as the recalling firmJun 14, 200210 years or older, so it adds no points0
Class II recall B-0628-3, this FEI as the recalling firmMay 8, 200210 years or older, so it adds no points0
Class II recall B-0270-3, this FEI as the recalling firmMar 11, 200210 years or older, so it adds no points0
Class II recall B-0359-3, this FEI as the recalling firmMar 4, 200210 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
West Henrietta, NY (US)
Source
inspections

FDA data resources

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