Department Of Defense - Air Force FDA Inspection Record

FEI 1577551 · Inspections, Form 483s, warning letters and import refusals

Department Of Defense - Air Force is an FDA-inspected facility (FEI 1577551) located in Dayton, OH, US. RegDataLab tracks 7 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Apr 14, 2025: Voluntary Action Indicated (VAI)
Inspections on record
7 (3 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
5, latest Mar 1, 2022

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 14, 2025Voluntary Action Indicated (VAI)Notification w/in 8 weeks (21 CFR 630.40(c))
Mar 30, 2022No Action Indicated (NAI)Proof Of Identity (21 CFR 630.10(g)(1))
Sep 26, 2019Voluntary Action Indicated (VAI)Notify Consignees [Collecting Establishment] (21 CFR 610.47(a)(3))
Determination of lot numbers and supplies (21 CFR 606.160(a)(2))
Sep 19, 2017No Action Indicated (NAI)No citations listed
Aug 7, 2015Voluntary Action Indicated (VAI)Provide space for examination (21 CFR 606.40(a)(1))
When to report (21 CFR 600.14(c))
Dec 21, 2012No Action Indicated (NAI)No citations listed
Dec 21, 2010No 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 1, 2022Class IIB-0365-2022Red Blood Cells, Leukocytes Reduced
Leukoreduced Red Blood Cells, collected from a donor who had recently traveled to a malarial endemic area, were distributed.
Sep 23, 2021Class IIB-0059-2022Red Blood Cells, Leukocytes Reduced and 3 more products
Blood products, not tested according to specifications, were distributed.
Nov 18, 2008Class IIB-0544-15Fresh Frozen Plasma and 1 more product
Blood products, which were incorrectly tested for HIV/HCV NAT using expired reagents, were distributed.
Jun 23, 2006Class IIB-1971-13Red Blood Cells
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Jul 15, 2005Class IIB-0781-6Fresh Frozen Plasma
Blood product, mislabeled as to ABO/Rh, was distributed.

Form 483s and inspection documents

  • 483 on FDA.gov
    Inspection Apr 8, 2025 to Apr 14, 2025, issued Apr 14, 2025 (dates printed on the document). FDA listing date Apr 14, 2025. Published by FDA Oct 26, 2026.

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 - Air Force
Location
Dayton, OH (US)
Source
inspections

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