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Department Of Defense - Army FDA Inspection Record

FEI 1677436 · Inspections, Form 483s, warning letters and import refusals

Department Of Defense - Army is an FDA-inspected facility (FEI 1677436) located in Fort Bliss, TX, US. RegDataLab tracks 7 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Jan 28, 2025: No Action Indicated (NAI)
Inspections on record
7 (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
6, latest Mar 24, 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
Jan 28, 2025No Action Indicated (NAI)No citations listed
Jun 3, 2019No Action Indicated (NAI)No citations listed
Jul 18, 2017No Action Indicated (NAI)No citations listed
Dec 2, 2014No Action Indicated (NAI)No citations listed
Nov 27, 2012No Action Indicated (NAI)No citations listed
Nov 23, 2010No Action Indicated (NAI)No citations listed
Feb 3, 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
Mar 24, 2026Class IIB-0276-2026Red Blood Cells and 4 more products
Red Blood Cells, for which arm preparation may have been performed incorrectly, were distributed.
Jun 8, 2020Class IIIB-0597-2020Whole Blood CPDA-1
Blood product, collected using expired blood collection sets, was distributed.
Mar 23, 2017Class IIIB-0592-2017Red Blood Cells
Blood products, collected from ineligible donors, were distributed.
Aug 11, 2016Class IIB-0747-16Apheresis Fresh Frozen Plasma
Apheresis product, collected from a donor who previously tested repeat reactive for anti-HTLV on two separate occasions, was distributed.
Aug 5, 2016Class IIB-0765-16Red Blood Cells
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
May 12, 2016Class IIB-0607-16Red Blood Cells and 2 more products
Blood products, collected from ineligible donors, were distributed.

FDA record score

4 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.

4 records behind this number
RecordDatePoints x age weightAdds
Class II recall B-0276-2026, this FEI as the recalling firmMar 24, 20264 x 14
Class II recall B-0747-16, this FEI as the recalling firmAug 11, 201610 years or older, so it adds no points0
Class II recall B-0765-16, this FEI as the recalling firmAug 5, 201610 years or older, so it adds no points0
Class II recall B-0607-16, this FEI as the recalling firmMay 12, 201610 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

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Facility details

Company
Department Of Defense - Army
Location
Fort Bliss, TX (US)
Source
inspections

FDA data resources

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