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CSL Behring LLC FDA Inspection Record

FEI 1410248 · Inspections, Form 483s, warning letters and import refusals

CSL Behring LLC is an FDA-registered facility (FEI 1410248) located in Bradley, IL, US. RegDataLab tracks 13 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Mar 2, 2023: Voluntary Action Indicated (VAI)
Inspections on record
13 (10 VAI, 3 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Recalls as the recalling firm
4, latest Jan 20, 2021

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

Showing the 10 most recent of 13 inspections. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Mar 2, 2023Voluntary Action Indicated (VAI)No citations listed
Sep 24, 2021Voluntary Action Indicated (VAI)No citations listed
May 23, 2019Voluntary Action Indicated (VAI)No citations listed
Oct 18, 2018Voluntary Action Indicated (VAI)No citations listed
Jul 19, 2017Voluntary Action Indicated (VAI)No citations listed
Sep 1, 2015No Action Indicated (NAI)No citations listed
Jul 17, 2015Voluntary Action Indicated (VAI)No citations listed
Jul 28, 2014Voluntary Action Indicated (VAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Scientifically sound laboratory controls (21 CFR 211.160(b))
May 30, 2013No Action Indicated (NAI)No citations listed
Sep 10, 2012No Action Indicated (NAI)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
Jan 20, 2021Class IIIB-0566-2021Coagulation Factor IX (Human) and 1 more product
Zemaira and Mononine, manufactured in a manner that could affect product sterility, were distributed.
Jun 3, 2019Class IIB-0802-2019Alpha-1-Proteinase Inhibitor (Human) and 1 more product
Batches of Alpha1-Proteinase Inhibitor (Human) and Coagulation Factor IX (Human), with the potential for inadequate aseptic technique during…
Aug 18, 2008Class IIIB-1892-08Monoclate-P Antihemophilic Factor (Human), 1000 units, Factor VIII:C Pasteurized…
Monoclate-P lots, which did not meet the potency assay requirements for stability testing at 3 months at 5 degrees C storage, were…
Aug 26, 2005Class IIB-2387-5Albumin (Human) 25% in 100 mL vials
Human Albumin, that may have been distributed with a stopper that allowed product leakage, was distributed.

FDA record score

8 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 15, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

12 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIMar 2, 20236 x 0.63.6
Inspection classified VAISep 24, 20216 x 0.251.5
Inspection classified VAIMay 23, 20196 x 0.251.5
Class II recall B-0802-2019, this FEI as the recalling firmJun 3, 20194 x 0.251
Inspection classified VAIOct 18, 2018Only the 3 most recent VAI inspections add points0
Inspection classified VAIJul 19, 2017Only the 3 most recent VAI inspections add points0
Inspection classified VAIJul 17, 201510 years or older, so it adds no points0
Inspection classified VAIJul 28, 201410 years or older, so it adds no points0
Inspection classified VAIFeb 3, 201110 years or older, so it adds no points0
Inspection classified VAIJun 5, 200910 years or older, so it adds no points0
Inspection classified VAIMar 26, 200910 years or older, so it adds no points0
Class II recall B-2387-5, this FEI as the recalling firmAug 26, 200510 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
CSL Behring L.L.C.
Location
Bradley, IL (US)
Source
device

FDA data resources

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