Overview
- 15 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-10-30.
At a glance
Inspections
15
Form 483s
8
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Oct 2024 – 30 Oct 2024 | Biologics | Clean | |
| 15 Aug 2022 – 26 Aug 2022 | Human Drugs | 483 | View 483 → |
| 13 Nov 2019 – 21 Nov 2019 | Biologics | 483 | On file |
| 11 Sep 2018 – 21 Sep 2018 | Biologics | 483 | On file |
| 29 Nov 2016 – 13 Dec 2016 | Human Drugs | 483 | On file |
| 19 May 2015 – 4 Jun 2015 | Biologics | 483 | On file |
| 10 Sep 2013 – 19 Sep 2013 | Biologics | 483 | On file |
| 12 Aug 2011 | Not recorded | 483 | On file |
| 19 Jun 2009 | Not recorded | 483 | On file |
| 27 Jun 2008 | Not recorded | Clean | |
| 24 Aug 2007 | Not recorded | Clean | |
| 22 Apr 2005 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Aug 2022
21 CFR 211.100(b)
Procedure Deviations Recorded and Justified
Cited by Christopher R Czajka
Investigators
FDA investigators tied to this site in the record.
Prabhu P Raju2 insp.
Omotunde O Osunsanmi2 insp.
Jacqueline M Diaz Albert2 insp.
Thai D Truong1 insp.
Brentley S Pittman1 insp.
Christopher R Czajka1 insp.
Linda Thai1 insp.
Daniel Lagasse1 insp.
Zuben E Sauna1 insp.
Elmina E Akwo1 insp.
Vijaya L Simhadri1 insp.
Stephanie A Slater1 insp.
James C Lee1 insp.
Simone E Pitts1 insp.
Christian Lynch1 insp.
Susan M Jackson1 insp.
Paula A Trost1 insp.
Helen B Ricalde1 insp.
Nancy T Waites1 insp.
Joseph George1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Bayer HealthCare LLC's 8 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