Overview
- 9 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-05-15.
At a glance
Inspections
9
Form 483s
4
EIRs
2
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 May 2025 – 15 May 2025 | Human Drugs | Clean | |
| 9 Sep 2019 – 13 Sep 2019 | Human Drugs | Clean | |
| 26 Apr 2018 – 4 May 2018 | Human Drugs | 483 | On file |
| 29 Feb 2016 – 8 Mar 2016 | Human Drugs | 483 | View 483 → |
| 19 Jan 2015 – 23 Jan 2015 | Medical Devices & Rad Health | Clean | |
| 24 Feb 2014 – 7 Mar 2014 | Human Drugs | 483 | On file |
| 12 Nov 2012 | Not recorded | WL | On file |
| 5 Feb 2010 | Not recorded | Clean | |
| 5 Jun 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Mar 2016
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Michael A Charles, Roger F Zabinski
8 Mar 2016
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Michael A Charles, Roger F Zabinski
8 Mar 2016
21 CFR 211.110(c)
In-process materials characteristics testing
Cited by Michael A Charles, Roger F Zabinski
8 Mar 2016
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Michael A Charles, Roger F Zabinski
8 Mar 2016
21 CFR 211.125(a)
Strict control not exercised over labeling issued
Cited by Michael A Charles, Roger F Zabinski
Investigators
FDA investigators tied to this site in the record.
MRA MunizN1 insp.
James R Birkenstamm1 insp.
Christopher S Keating1 insp.
Michael A Charles1 insp.
Roger F Zabinski1 insp.
Thomas E Friel1 insp.
Margaret M Annes1 insp.
Andrew J Idzior1 insp.
Erika E Englund1 insp.
Steven M Weinman1 insp.
Denise M Digiulio1 insp.
Mary E Storch1 insp.
Temar Q Williams1 insp.
Megan A Haggerty1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Boehringer Ingelheim Pharma GmbH & Co. KG's 4 Form 483s
Source PDFs 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