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Mission Hospitals Transfusion Service FDA Record

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

Mission Hospitals Transfusion Service has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Mission Hospitals Transfusion Service" is on file. FDA has published 1 Form 483 for Mission Hospitals Transfusion Service.

What these totals cover: FDA records filed under the name "Mission Hospitals Transfusion Service".

Latest inspection: May 15, 2025 · VAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	8	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

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

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	1	0	0	0	0
2024	0	0	0	0	0
2023	1	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	1	0	0	0	0
2018	0	0	0	0	0
2017	1	0	0	0	0

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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Mission Hospitals Transfusion Service Form 483s

1 Form 483 published by FDA.

Date	Document	FEI
May 15, 2025	483	1000140351

A Form 483 lists the observations FDA investigators made at the end of an inspection. FDA publishes some Form 483s in its reading room, and each date links to that document. Read the observations with the FDA 483 search.

Recent FDA inspections

8 inspections from Jun 10, 2009 to May 15, 2025.

Date	Site	Product	Classification	FEI
May 15, 2025	Asheville, NC	Biologics	Voluntary Action Indicated (VAI)	1000140351
Jan 24, 2023	Asheville, NC	Biologics	No Action Indicated (NAI)	1000140351
Jul 9, 2019	Asheville, NC	Biologics	No Action Indicated (NAI)	1000140351
Mar 30, 2017	Asheville, NC	Biologics	No Action Indicated (NAI)	1000140351
Feb 2, 2015	Asheville, NC	Biologics	No Action Indicated (NAI)	1000140351
May 10, 2013	Asheville, NC	Biologics	No Action Indicated (NAI)	1000140351
Mar 4, 2011	Asheville, NC	Biologics	No Action Indicated (NAI)	1000140351
Jun 10, 2009	Asheville, NC	Biologics	No Action Indicated (NAI)	1000140351

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.

Facility	Location	Inspections	Latest
FEI 1000140351	Asheville, NC	8	May 15, 2025

Mission Hospitals Transfusion Service and the FDA: common questions

Has Mission Hospitals Transfusion Service received an FDA warning letter?

No FDA warning letter addressed to the name "Mission Hospitals 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 Mission Hospitals Transfusion Service received an FDA Form 483?

FDA has published 1 Form 483 for Mission Hospitals Transfusion Service in its reading room, the most recent dated May 15, 2025. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Mission Hospitals Transfusion Service?

The most recent FDA inspection on file ended May 15, 2025 at Asheville, NC and was classified VAI. FDA has 8 inspections of Mission Hospitals Transfusion Service on file.

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