Ascension Sacred Heart Hospital Transfusion Service FDA Record

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

  • Latest inspection NAI · Jul 15, 2025
  • No warning letters matched by name
Inspections 4 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 0 None on file

Ascension Sacred Heart Hospital Transfusion Service has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Ascension Sacred Heart Hospital Transfusion Service" is on file.

What these totals cover: FDA records filed under the name "Ascension Sacred Heart Hospital Transfusion Service".

Latest inspection
Jul 15, 2025 · NAI

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
Inspections4Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Ascension Sacred Heart Hospital Transfusion Service's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Ascension Sacred Heart Hospital Transfusion Service: FDA inspections per year

YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202510000
202400000
202300000
202210000
202100000
202000000
201900000
201810000
201700000

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

4 inspections from Mar 22, 2016 to Jul 15, 2025.

DateSiteProductClassificationFEI
Jul 15, 2025Pensacola, FLBiologicsNo Action Indicated (NAI)3001542496
Nov 4, 2022Pensacola, FLBiologicsNo Action Indicated (NAI)3001542496
Aug 24, 2018Pensacola, FLBiologicsVoluntary Action Indicated (VAI)3001542496
Mar 22, 2016Pensacola, FLBiologicsNo Action Indicated (NAI)3001542496
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 3001542496Pensacola, FL4Jul 15, 2025

Ascension Sacred Heart Hospital Transfusion Service and the FDA: common questions

Has Ascension Sacred Heart Hospital Transfusion Service received an FDA warning letter?

No FDA warning letter addressed to the name "Ascension Sacred Heart Hospital Transfusion Service" 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 Ascension Sacred Heart Hospital Transfusion Service received an FDA Form 483?

FDA has not published a Form 483 for "Ascension Sacred Heart Hospital Transfusion Service" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Ascension Sacred Heart Hospital Transfusion Service?

The most recent FDA inspection on file ended Jul 15, 2025 at Pensacola, FL and was classified NAI. FDA has 4 inspections of Ascension Sacred Heart Hospital Transfusion Service on file.

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