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Smithfield Bioscience Inc

FDA Regulatory Profile

Smithfield Bioscience Inc has 0 FDA recalls, 9 inspections, 0 510(k) clearances and 1 compliance action on record.

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

Latest inspection: Dec 23, 2025 · OAI

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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	9	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Smithfield Bioscience 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
2026	0	0
2025	1	1
2024	0	0
2023	0	0
2022	1	0
2021	0	0
2020	0	0
2019	1	0
2018	0	0
2017	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.

Recent FDA inspections

9 inspections from Jun 11, 2009 to Dec 23, 2025.

Date	Site	Product	Classification	FEI
Dec 23, 2025	Cincinnati, OH	Drugs	Official Action Indicated (OAI)	1527761
Jul 15, 2022	Cincinnati, OH	Drugs	Voluntary Action Indicated (VAI)	1527761
May 15, 2019	Cincinnati, OH	Drugs	Voluntary Action Indicated (VAI)	1527761
Oct 27, 2016	Cincinnati, OH	Drugs	Voluntary Action Indicated (VAI)	1527761
Nov 14, 2014	Cincinnati, OH	Drugs	Voluntary Action Indicated (VAI)	1527761
May 25, 2012	Cincinnati, OH	Drugs	Voluntary Action Indicated (VAI)	1527761
Dec 13, 2011	Cincinnati, OH	Drugs	No Action Indicated (NAI)	1527761
Mar 28, 2011	Cincinnati, OH	Drugs	No Action Indicated (NAI)	1527761
Jun 11, 2009	Cincinnati, OH	Drugs	No Action Indicated (NAI)	1527761

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.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Smithfield Bioscience Inc: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Seizure, Nov 6, 2008.

Individual actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 1527761	Cincinnati, OH	9	Dec 23, 2025

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