CSL Behring L.L.C., Bradley: FDA Inspections, Form 483s & Citations

Overview

23 FDA inspections are on record.
12 inspections produced a Form 483.
The most recent recorded inspection date is 2023-03-02.

At a glance

Inspections

Form 483s

EIRs

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

Inspection	Category	Outcome	Form 483
21 Feb 2023 – 2 Mar 2023	Biologics	483	On file
13 Sep 2021 – 24 Sep 2021	Biologics	483	On file
13 May 2019 – 23 May 2019	Biologics	483	On file
15 Oct 2018 – 18 Oct 2018	Biologics	483	On file
11 Jul 2017 – 19 Jul 2017	Biologics	483	On file
1 Sep 2015	Medical Devices & Rad Health	Clean
7 Jul 2015 – 17 Jul 2015	Biologics	483	On file
16 Jul 2014 – 28 Jul 2014	Human Drugs	483	View 483 →
23 Jun 2014 – 27 Jun 2014	Biologics	483	On file
5 Jun 2013 – 13 Jun 2013	Biologics	483	On file
29 May 2013 – 30 May 2013	Human Drugs	Clean
10 Sep 2012	Not recorded	Clean
3 Feb 2011	Not recorded	483	On file
5 Jun 2009	Not recorded	483	On file
26 Mar 2009	Not recorded	483	On file
16 May 2008	Not recorded	Clean
24 Jan 2008	Not recorded	Clean
26 Jan 2007	Not recorded	Clean
4 Mar 2005	Not recorded	Clean
20 Nov 2003	Not recorded	Clean
1 Apr 2003	Not recorded	Clean
6 Jun 2002	Not recorded	Clean
24 May 2001	Not recorded	Clean

Observations on record

Form 483 observations cited at this site, most recent first.

28 Jul 2014

21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Brian D Nicholson

28 Jul 2014

21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Brian D Nicholson

Investigators

FDA investigators tied to this site in the record.

Debra M Emerson2 insp.

Prabhu P Raju2 insp.

Mihaly S Ligmond2 insp.

Brian D Nicholson2 insp.

Russell K Riley2 insp.

Brentley S Collins1 insp.

Unnee Ranjan1 insp.

Claire M Minden1 insp.

Richard T Riggie1 insp.

Randall L Morris1 insp.

Laura Fontan1 insp.

Yonggang Wang1 insp.

Gregory A Price1 insp.

Susan M Jackson1 insp.

John M Seale1 insp.

Gene D Arcy1 insp.

Richard H Coats1 insp.

Sean R Byrd1 insp.

Jacqueline M Diaz Albert1 insp.

Ashley L Reiber1 insp.

Burnell M Henry1 insp.

Deborah M Trout1 insp.

Samuel W Labinjo1 insp.

Jennifer L Schmidt1 insp.

Omotunde O Osunsanmi1 insp.

Carrie-Ann Plucinski1 insp.

Susan P Bruederle1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

Citation	What it covers	Cited
21 CFR 211.160(b)	Cited across public-safe Form 483 observations	1x
21 CFR 211.22(d)	Cited across public-safe Form 483 observations	1x

Full site report

Get the verbatim findings behind CSL Behring L.L.C.'s 12 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.

The site's full inspection history, with every Form 483 and its outcome
Warning letters and recalls tied to the company behind it
Whether recurring CFR citations get closed out or repeat