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Octapharma AB — FDA Facility Profile

FEI 3005559915

Octapharma AB is an FDA-registered facility (FEI 3005559915) located in SE-11275, SE. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 6 FDA inspections and 1 compliance action at this facility.

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What FDA found at this site

Latest inspection
Sep 19, 2023: Voluntary Action Indicated (VAI)
Inspections on record
6 (1 OAI, 5 VAI)
Last OAI inspection
Jan 20, 2011
Warning letters
1 listed by FDA for this FEI, latest Apr 15, 2011
Form 483 and inspection documents
1 in FDA's reading room
Recalls as the recalling firm
1, latest Nov 8, 2021
Import refusals
1

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Sep 19, 2023Voluntary Action Indicated (VAI)Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a))
Procedure Deviations Recorded and Justified (21 CFR 211.100(b))
Written in-process control procedures (21 CFR 211.110(a))
Sep 28, 2018Voluntary Action Indicated (VAI)No citations listed
Apr 28, 2014Voluntary Action Indicated (VAI)No citations listed
Jan 19, 2012Voluntary Action Indicated (VAI)No citations listed
Jan 20, 2011Official Action Indicated (OAI)No citations listed
Jan 29, 2009Voluntary Action Indicated (VAI)No citations listed

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Nov 8, 2021Not yet classifiedB-0095-2022Antihemophilic Factor (Recombinant)
Factor FVIII, labeled with the incorrect concentration, was distributed.

Form 483s and inspection documents

Facility details

Company
Octapharma AB
Location
SE-11275 (SE)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK
Source
decrs

Compliance actions

Import refusals

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.