Home / Facilities / 3001451955

American National Red Cross (The), Lewis And Clark Region FDA Inspection Record

FEI 3001451955 · Inspections, Form 483s, warning letters and import refusals

American National Red Cross (The), Lewis And Clark Region is an FDA-inspected facility (FEI 3001451955) located in Murray, UT, US. RegDataLab tracks 10 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Mar 31, 2023: No Action Indicated (NAI)
Inspections on record
10 (6 VAI, 4 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
46, latest Jan 20, 2026

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
Mar 31, 2023No Action Indicated (NAI)Concurrent documentation (21 CFR 606.160(a)(1))
May 25, 2018No Action Indicated (NAI)No citations listed
Aug 30, 2017No Action Indicated (NAI)No citations listed
Aug 15, 2017No Action Indicated (NAI)No citations listed
Apr 16, 2015Voluntary Action Indicated (VAI)Qualifications of responsible personnel (21 CFR 606.20(b))
Thorough investigations (21 CFR 606.100(c))
May 9, 2014Voluntary Action Indicated (VAI)No citations listed
Sep 20, 2013Voluntary Action Indicated (VAI)Calibration/Inspection/Checking not done (21 CFR 211.68(a))
Provide proper equipment to meet requirements (21 CFR 606.60(a))
Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b))
Thorough investigations (21 CFR 606.100(c))
Sep 28, 2012Voluntary Action Indicated (VAI)No citations listed
Sep 30, 2011Voluntary Action Indicated (VAI)No citations listed
Mar 23, 2010Voluntary Action Indicated (VAI)Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b))
Thorough investigations (21 CFR 606.100(c))

Recalls

Showing the 10 most recent of 46 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
Jan 20, 2026Class IIB-0225-2026Red Blood Cells, Leukocytes Reduced, Irradiated
Misbranded Red Blood Cells, Leukocytes Reduced, Irradiated, were distributed.
Oct 6, 2025Class IIB-0227-2026Apheresis Red Blood Cells, Leukocytes Reduced
Misbranded Apheresis Red Blood Cells, Leukocytes Reduced, were distributed.
Oct 3, 2025Class IIB-0006-2027Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced
Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced, which were exposed to unacceptable storage temperatures, were distributed.
Feb 16, 2025Class IIIB-0009-2026Apheresis Red Blood Cells, Leukocytes Reduced
Apheresis Red Blood Cells, Leukocytes Reduced, for which a visual inspection was not performed or documented, were distributed.
Dec 6, 2024Class IIB-0214-2025Red Blood Cells, Leukocytes Reduced
Leukoreduced Red Blood Cells, collected from a donor with a history of a positive test result for Babesia, were distributed.
Nov 19, 2024Class IIB-0199-2025Apheresis Red Blood Cells, Leukocytes Reduced
Apheresis red blood cells, leukocytes reduced, which were labeled as leukocytes reduced but failed the monthly QC residual white blood cell…
Sep 10, 2024Class IIB-0350-2025Red Blood Cells, Leukocytes Reduced
Red Blood Cells. Leukocytes Reduced, which were labeled as antigen negative, but were collected from a donor who subsequently tested antigen…
May 23, 2024Class IIIB-0210-2025Apheresis Red Blood Cells, Leukocytes Reduced
Leukoreduced Apheresis Red Blood Cells product, which was labeled with an incorrect volume, was distributed.
Aug 31, 2023Class IIB-0157-2024Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced
Platelet products, collected on an instrument for which validation and quality control testing was not performed, were distributed.
Aug 15, 2023Class IIB-0195-2024Whole Blood, Leukocytes Reduced
Blood products, identified as unsuitable due to a component preparation deviation, were distributed.

Form 483s and inspection documents

  • 483 on FDA.gov
    Issued May 23, 2008 (dates printed on the document). FDA listing date Jul 11, 2015. Published by FDA Jan 18, 2024.

FDA record score

57 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 15, 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.

41 records behind this number
RecordDatePoints x age weightAdds
Class II recall B-0225-2026, this FEI as the recalling firmJan 20, 20264 x 14
Class II recall B-0227-2026, this FEI as the recalling firmOct 6, 20254 x 14
Class II recall B-0006-2027, this FEI as the recalling firmOct 3, 20254 x 14
Class II recall B-0214-2025, this FEI as the recalling firmDec 6, 20244 x 14
Class II recall B-0199-2025, this FEI as the recalling firmNov 19, 20244 x 14
Class II recall B-0350-2025, this FEI as the recalling firmSep 10, 20244 x 0.62.4
Class II recall B-0157-2024, this FEI as the recalling firmAug 31, 20234 x 0.62.4
Class II recall B-0195-2024, this FEI as the recalling firmAug 15, 20234 x 0.62.4
Class II recall B-0158-2024, this FEI as the recalling firmJul 18, 20234 x 0.62.4
Class II recall B-0355-2025, this FEI as the recalling firmFeb 9, 20234 x 0.62.4
Class II recall B-0352-2023, this FEI as the recalling firmNov 21, 20224 x 0.62.4
Class II recall B-0143-2023, this FEI as the recalling firmJul 20, 20224 x 0.62.4
Class II recall B-0100-2023, this FEI as the recalling firmMay 13, 20224 x 0.62.4
Class II recall B-0140-2022, this FEI as the recalling firmDec 14, 20214 x 0.62.4
Class II recall B-0137-2022, this FEI as the recalling firmNov 15, 20214 x 0.62.4
Class II recall B-0328-2021, this FEI as the recalling firmJan 19, 20214 x 0.251
Class II recall B-0411-2021, this FEI as the recalling firmJan 19, 20214 x 0.251
Class II recall B-0315-2021, this FEI as the recalling firmJan 2, 20214 x 0.251
Class II recall B-0214-2021, this FEI as the recalling firmDec 18, 20204 x 0.251
Class II recall B-0080-2021, this FEI as the recalling firmJul 16, 20204 x 0.251
Class II recall B-0720-2019, this FEI as the recalling firmMay 4, 20194 x 0.251
Class II recall B-0785-2019, this FEI as the recalling firmApr 25, 20194 x 0.251
Class II recall B-0692-2019, this FEI as the recalling firmMar 8, 20194 x 0.251
Class II recall B-0646-2019, this FEI as the recalling firmFeb 11, 20194 x 0.251
Class II recall B-0658-2019, this FEI as the recalling firmJan 29, 20194 x 0.251
Class II recall B-0837-2017, this FEI as the recalling firmJul 14, 20174 x 0.251
Class II recall B-0836-2017, this FEI as the recalling firmJun 14, 20174 x 0.251
Class II recall B-0702-2017, this FEI as the recalling firmApr 5, 20174 x 0.251
Inspection classified VAIApr 16, 201510 years or older, so it adds no points0
Inspection classified VAIMay 9, 201410 years or older, so it adds no points0
Inspection classified VAISep 20, 201310 years or older, so it adds no points0
Class II recall B-0081-14, this FEI as the recalling firmMay 31, 201310 years or older, so it adds no points0
Inspection classified VAISep 28, 201210 years or older, so it adds no points0
Class II recall B-0050-13, this FEI as the recalling firmJun 22, 201210 years or older, so it adds no points0
Inspection classified VAISep 30, 201110 years or older, so it adds no points0
Class II recall B-0147-13, this FEI as the recalling firmNov 15, 201010 years or older, so it adds no points0
Inspection classified VAIMar 23, 201010 years or older, so it adds no points0
Class II recall B-0099-14, this FEI as the recalling firmFeb 13, 200810 years or older, so it adds no points0
Class II recall B-1469-13, this FEI as the recalling firmMar 9, 200710 years or older, so it adds no points0
Class II recall B-0206-6, this FEI as the recalling firmDec 11, 200010 years or older, so it adds no points0
Class II recall B-0200-6, this FEI as the recalling firmMar 12, 199910 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 15, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 15, 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 15, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 15, 2026Newest record Nov 5, 2026Current

Reviewing American National Red Cross (The), Lewis And Clark Region as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check American National Red Cross (The), Lewis And Clark Region yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Facility details

Company
American National Red Cross (The), Lewis And Clark Region
Location
Murray, UT (US)
Source
inspections

FDA data resources

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