Swedish Orphan Biovitrum AB (Publ) FDA Record

Summary

FDA record by year

Swedish Orphan Biovitrum AB (Publ)'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

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 20, 2009 to Aug 29, 2019.

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.

Swedish Orphan Biovitrum AB (Publ) and the FDA: common questions

Has Swedish Orphan Biovitrum AB (Publ) received an FDA warning letter?

No FDA warning letter addressed to the name "Swedish Orphan Biovitrum AB (Publ)" 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 Swedish Orphan Biovitrum AB (Publ) received an FDA Form 483?

FDA has not published a Form 483 for "Swedish Orphan Biovitrum AB (Publ)" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Swedish Orphan Biovitrum AB (Publ)?

The most recent FDA inspection on file ended Aug 29, 2019 at Stockholm, Sweden and was classified NAI. FDA has 7 inspections of Swedish Orphan Biovitrum AB (Publ) on file.