Boehringer Ingelheim Pharma GmbH and Co. KG, Biberach An Der Ris: FDA Inspections, Form 483s & Citations

Overview

23 FDA inspections are on record.
13 inspections produced a Form 483.
The most recent recorded inspection date is 2022-07-22.

At a glance

Inspections

Form 483s

EIRs

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

Inspection	Category	Outcome	Form 483
7 Mar 2022 – 22 Jul 2022	Human Drugs	Clean
9 Sep 2019 – 19 Sep 2019	Human Drugs	483	View 483 →
12 Aug 2019 – 15 Aug 2019	Human Drugs	Clean
1 Apr 2019 – 5 Apr 2019	Human Drugs	483	View 483 →
15 Oct 2018 – 19 Oct 2018	Human Drugs	Clean
17 Sep 2018 – 21 Sep 2018	Human Drugs	483	On file
2 Jul 2018 – 10 Jul 2018	Human Drugs	483	On file
15 May 2017 – 26 May 2017	Human Drugs	483	On file
8 Aug 2016 – 10 Aug 2016	Human Drugs	Clean
21 Jan 2016 – 25 Jan 2016	Human Drugs	Clean
9 Nov 2015 – 13 Nov 2015	Human Drugs	483	On file
3 Aug 2015 – 11 Aug 2015	Human Drugs	483	On file
19 May 2014 – 30 May 2014	Human Drugs	483	On file
11 Mar 2013 – 19 Mar 2013	Human Drugs	Clean
13 Mar 2012	Not recorded	483	On file
26 May 2010	Not recorded	483	On file
28 Jan 2010	Not recorded	Clean
19 May 2009	Not recorded	483	On file
31 Jul 2008	Not recorded	483	On file
20 Jun 2008	Not recorded	WL	On file
5 Apr 2005	Not recorded	Clean
20 Jun 2002	Not recorded	Clean
9 May 2000	Not recorded	Clean

Observations on record

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

19 Sep 2019

21 CFR 211.100(b)

SOPs not followed / documented

Cited by Erika V Butler

19 Sep 2019

21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Erika V Butler

19 Sep 2019

21 CFR 211.192

Investigations of discrepancies, failures

Cited by Erika V Butler

5 Apr 2019

21 CFR 211.160(a)

Lab controls established, including changes

Cited by Doan T Nguyen, Doan N Singh

5 Apr 2019

21 CFR 211.192

Investigations of discrepancies, failures

Cited by Doan T Nguyen, Doan N Singh

Investigators

FDA investigators tied to this site in the record.

Richard W Berning2 insp.

Thuy T Nguyen2 insp.

Wayne E Seifert2 insp.

MRA MunizN1 insp.

Erika V Butler1 insp.

Doan T Nguyen1 insp.

Doan N Singh1 insp.

Ziyang Su1 insp.

Diane L Raccasi1 insp.

Michael Shanks1 insp.

Zhong Li1 insp.

Anh Lac1 insp.

Veronica Fuentes1 insp.

Kathleen R Jones1 insp.

Monica M Commerford1 insp.

Yanming An1 insp.

Christopher D Downey1 insp.

Richard Ledwidge1 insp.

Zerita White1 insp.

Zhihao Pete Qiu1 insp.

Reyes Candau-Chacon1 insp.

Donald C Obenhuber1 insp.

Anita Narula1 insp.

Virgilio F Pacio1 insp.

Azza Talaat1 insp.

Kevin A Gonzalez1 insp.

Omotunde O Osunsanmi1 insp.

Mihaly S Ligmond1 insp.

Mary E Storch1 insp.

Kalavati C Suvarna1 insp.

Bo Chi1 insp.

Brenda W Uratani1 insp.

Michelle Y Clark Stuart1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

Citation	What it covers	Cited
21 CFR 211.192	Cited across public-safe Form 483 observations	2x
21 CFR 211.100(b)	Cited across public-safe Form 483 observations	1x
21 CFR 211.113(b)	Cited across public-safe Form 483 observations	1x
21 CFR 211.160(a)	Cited across public-safe Form 483 observations	1x

Full site report

Get the verbatim findings behind Boehringer Ingelheim Pharma GmbH and Co. KG's 13 Form 483s

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