Overview
- 15 FDA inspections are on record.
- 11 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-12-13.
At a glance
Inspections
15
Form 483s
11
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 Dec 2023 – 13 Dec 2023 | Biologics | 483 | On file |
| 21 Sep 2021 – 29 Sep 2021 | Biologics | 483 | View 483 → |
| 30 Sep 2019 – 4 Oct 2019 | Biologics | 483 | On file |
| 20 Sep 2018 – 27 Sep 2018 | Biologics | 483 | On file |
| 13 Jun 2016 – 16 Jun 2016 | Biologics | Clean | |
| 12 Apr 2016 – 19 Apr 2016 | Biologics | 483 | On file |
| 5 Nov 2013 – 14 Nov 2013 | Biologics | 483 | On file |
| 9 Sep 2011 | Not recorded | 483 | On file |
| 10 Dec 2009 | Not recorded | 483 | On file |
| 20 Mar 2008 | Not recorded | 483 | On file |
| 18 May 2006 | Not recorded | Clean | |
| 20 May 2004 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Sep 2021
21 CFR 211.170(b)
Reserve samples identified, representative, stored
Cited by Brentley S Collins, Linda Thai
Investigators
FDA investigators tied to this site in the record.
Brentley S Collins2 insp.
Gene D Arcy2 insp.
Alan L Truong1 insp.
Brentley S Pittman1 insp.
Linda Thai1 insp.
Christine Harman1 insp.
David E Bailey1 insp.
Holly Brevig1 insp.
Jennifer L Bridgewater1 insp.
Steven C Derrick1 insp.
Donald B Ertel1 insp.
Joan Johnson1 insp.
Prabhu P Raju1 insp.
Susan M Jackson1 insp.
Mihaly S Ligmond1 insp.
Cynthia Jim1 insp.
Michele L Forster1 insp.
Julie D Bringger1 insp.
Christian Lynch1 insp.
Omotunde O Osunsanmi1 insp.
Rose M Ashley1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Emergent BioDefense Operations Lansing LLC's 11 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