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Octapharma Pharmazeutika Produktionsgesellschaft M.B.H. FDA Record

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

Latest inspection VAI · Dec 16, 2022
No warning letters matched by name

Inspections 5

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Octapharma Pharmazeutika Produktionsgesellschaft M.B.H. has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Octapharma Pharmazeutika Produktionsgesellschaft M.B.H." is on file.

What these totals cover: FDA records filed under the name "Octapharma Pharmazeutika Produktionsgesellschaft M.B.H." and its spelling variant "Octapharma Pharmazeutika Produktionsgesellschaft M.B.H".

Latest inspection: Dec 16, 2022 · VAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 11, 2026 (checked Nov 15, 2026, unchanged)	File dated Nov 10, 2026	Current
510(k) clearances	0	Nov 15, 2026	File dated Nov 9, 2026	Current
Inspections	5	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Octapharma Pharmazeutika Produktionsgesellschaft M.B.H.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Octapharma Pharmazeutika Produktionsgesellschaft M.B.H.: FDA inspections per year

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	0	0	0	0	0
2022	1	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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Recent FDA inspections

5 inspections from Dec 18, 2012 to Dec 16, 2022.

Date	Site	Product	Classification	FEI
Dec 16, 2022	Vienna, Austria	Biologics	Voluntary Action Indicated (VAI)	3002809097
Apr 16, 2019	Vienna, Austria	Biologics	Voluntary Action Indicated (VAI)	3002809097
Jan 17, 2017	Vienna, Austria	Biologics	Voluntary Action Indicated (VAI)	3002809097
Mar 5, 2015	Vienna, Austria	Biologics	Voluntary Action Indicated (VAI)	3002809097
Dec 18, 2012	Vienna, Austria	Biologics	Voluntary Action Indicated (VAI)	3002809097

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 3002809097	Vienna, Austria	5	Dec 16, 2022

Octapharma Pharmazeutika Produktionsgesellschaft M.B.H. and the FDA: common questions

Has Octapharma Pharmazeutika Produktionsgesellschaft M.B.H. received an FDA warning letter?

No FDA warning letter addressed to the name "Octapharma Pharmazeutika Produktionsgesellschaft M.B.H." 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 Octapharma Pharmazeutika Produktionsgesellschaft M.B.H. received an FDA Form 483?

FDA has not published a Form 483 for "Octapharma Pharmazeutika Produktionsgesellschaft M.B.H." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Octapharma Pharmazeutika Produktionsgesellschaft M.B.H.?

The most recent FDA inspection on file ended Dec 16, 2022 at Vienna, Austria and was classified VAI. FDA has 5 inspections of Octapharma Pharmazeutika Produktionsgesellschaft M.B.H. on file.

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