VA Black Hills Health Care System - Fort Meade FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

  • Latest inspection VAI · Aug 26, 2025
  • No warning letters matched by name
Inspections 7 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 0 None on file

VA Black Hills Health Care System - Fort Meade has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "VA Black Hills Health Care System - Fort Meade" is on file.

What these totals cover: FDA records filed under the name "VA Black Hills Health Care System - Fort Meade".

Latest inspection
Aug 26, 2025 · VAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 11, 2026 (checked Nov 15, 2026, unchanged)File dated Nov 10, 2026Current
510(k) clearances0Nov 15, 2026File dated Nov 9, 2026Current
Inspections7Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

VA Black Hills Health Care System - Fort Meade's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

VA Black Hills Health Care System - Fort Meade: FDA inspections per year

YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202510000
202400000
202300000
202200000
202100000
202000000
201910000
201800000
201710000

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Recent FDA inspections

7 inspections from Apr 23, 2009 to Aug 26, 2025.

DateSiteProductClassificationFEI
Aug 26, 2025Fort Meade, SDBiologicsVoluntary Action Indicated (VAI)1774471
Jun 20, 2019Fort Meade, SDBiologicsNo Action Indicated (NAI)1774471
Jul 19, 2017Fort Meade, SDBiologicsNo Action Indicated (NAI)1774471
Jul 22, 2015Fort Meade, SDBiologicsNo Action Indicated (NAI)1774471
Feb 28, 2013Fort Meade, SDBiologicsNo Action Indicated (NAI)1774471
Jul 7, 2011Fort Meade, SDBiologicsNo Action Indicated (NAI)1774471
Apr 23, 2009Fort Meade, SDBiologicsNo Action Indicated (NAI)1774471
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 1774471Fort Meade, SD7Aug 26, 2025

VA Black Hills Health Care System - Fort Meade and the FDA: common questions

Has VA Black Hills Health Care System - Fort Meade received an FDA warning letter?

No FDA warning letter addressed to the name "VA Black Hills Health Care System - Fort Meade" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has VA Black Hills Health Care System - Fort Meade received an FDA Form 483?

FDA has not published a Form 483 for "VA Black Hills Health Care System - Fort Meade" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect VA Black Hills Health Care System - Fort Meade?

The most recent FDA inspection on file ended Aug 26, 2025 at Fort Meade, SD and was classified VAI. FDA has 7 inspections of VA Black Hills Health Care System - Fort Meade on file.

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