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Octapharma AB

FDA Regulatory Profile

Octapharma AB has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 1 compliance action on record.

What these totals cover: FDA records filed under the name "Octapharma AB" and its spelling variant "Octapharma".

Latest inspection: Sep 19, 2023 · 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	7	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

Octapharma AB'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	0	0	0	0	0
2023	1	0	0	0	0
2022	1	0	0	0	0
2021	0	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.

Recent FDA inspections

7 inspections from Jan 29, 2009 to Sep 19, 2023.

Date	Site	Product	Classification	FEI
Sep 19, 2023	Stockholm, Sweden	Biologics	Voluntary Action Indicated (VAI)	3005559915
Dec 6, 2022	Lingolsheim, France	Biologics	Voluntary Action Indicated (VAI)	3010600159
Sep 28, 2018	Stockholm, Sweden	Biologics	Voluntary Action Indicated (VAI)	3005559915
Apr 28, 2014	Stockholm, Sweden	Biologics	Voluntary Action Indicated (VAI)	3005559915
Jan 19, 2012	Stockholm, Sweden	Biologics	Voluntary Action Indicated (VAI)	3005559915
Jan 20, 2011	Stockholm, Sweden	Biologics	Official Action Indicated (OAI)	3005559915
Jan 29, 2009	Stockholm, Sweden	Biologics	Voluntary Action Indicated (VAI)	3005559915

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 Octapharma AB: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Apr 15, 2011.

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

FDA-inspected facilities

2 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3005559915	Stockholm, Sweden	6	Sep 19, 2023
FEI 3010600159	Lingolsheim, France	1	Dec 6, 2022

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