Department Of Defense - Army (Armed Services Blood Program) FDA Inspection Record

FEI 3002964709 · Inspections, Form 483s, warning letters and import refusals

Department Of Defense - Army (Armed Services Blood Program) is an FDA-inspected facility (FEI 3002964709) located in Landstuhl, DE. RegDataLab tracks 8 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Apr 10, 2025: No Action Indicated (NAI)
Inspections on record
8 (1 VAI, 7 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
3, latest Feb 21, 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
Apr 10, 2025No Action Indicated (NAI)No citations listed
Aug 23, 2023Voluntary Action Indicated (VAI)Adverse Reaction- Reports of Investigations (21 CFR 606.170(a))
Jun 6, 2019No Action Indicated (NAI)No citations listed
May 25, 2017No Action Indicated (NAI)No citations listed
May 15, 2015No Action Indicated (NAI)No citations listed
Jun 21, 2013No Action Indicated (NAI)No citations listed
Jun 21, 2011No Action Indicated (NAI)No citations listed
Jun 5, 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 21, 2024Class IIB-0249-2024Platelets, Leukocytes Reduced
Platelets leukocytes reduced product with a high yield count, was distributed.
Sep 17, 2019Class IIIB-0069-2020Whole Blood and 1 more product
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Aug 17, 2005Class IIIB-0169-07Red Blood Cells Unit (1 unit) 3968118
Blood product, collected from an ineligible donor due to the use of an antibiotic, was distributed.

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
Department Of Defense - Army (Armed Services Blood Program)
Location
Landstuhl (DE)
Source
inspections

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