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Kedrion Biopharma Inc. FDA Record

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

Kedrion Biopharma Inc. has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Kedrion Biopharma Inc." is on file. FDA has published 1 Form 483 for Kedrion Biopharma Inc..

What these totals cover: FDA records filed under the name "Kedrion Biopharma Inc." and its spelling variant "Kedrion Biopharma".

Latest inspection: Mar 27, 2024 · VAI

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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	6	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

Kedrion Biopharma Inc.'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	0	0	0	0	0
2024	1	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	1	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	1	0	0	0	0
2017	0	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.

Kedrion Biopharma Inc. Form 483s

1 Form 483 published by FDA.

Date	Document	FEI
Dec 6, 2019	483	3003683714

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

6 inspections from Jul 21, 2009 to Mar 27, 2024.

Date	Site	Product	Classification	FEI
Mar 27, 2024	Melville, NY	Biologics	Voluntary Action Indicated (VAI)	3003683714
Jun 25, 2021	Melville, NY	Biologics	Voluntary Action Indicated (VAI)	3003683714
Aug 29, 2018	Melville, NY	Biologics	Voluntary Action Indicated (VAI)	3003683714
Sep 29, 2014	Melville, NY	Biologics	Voluntary Action Indicated (VAI)	3003683714
Aug 2, 2012	Melville, NY	Biologics	Voluntary Action Indicated (VAI)	3003683714
Jul 21, 2009	Melville, NY	Biologics	Voluntary Action Indicated (VAI)	3003683714

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 3003683714	Melville, NY	6	Mar 27, 2024

Kedrion Biopharma Inc. and the FDA: common questions

Has Kedrion Biopharma Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "Kedrion Biopharma Inc." 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 Kedrion Biopharma Inc. received an FDA Form 483?

FDA has published 1 Form 483 for Kedrion Biopharma Inc. in its reading room, the most recent dated Dec 6, 2019. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Kedrion Biopharma Inc.?

The most recent FDA inspection on file ended Mar 27, 2024 at Melville, NY and was classified VAI. FDA has 6 inspections of Kedrion Biopharma Inc. on file.

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