Emergent Biodefense Operations Lansing LLC
FDA inspection history in Lansing, Michigan, 2000 to 2023
- 11
- Form 483s
Every document, by year
- Form 483
2000: two Form 483s; 2002: one Form 483; 2009: one Form 483; 2011: one Form 483; 2013: one Form 483; 2016: one Form 483; 2018: one Form 483; 2019: one Form 483; 2021: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2000–02Three Form 483s, at Lansing, Michigan.
- 2000The longest 483 on file: 25 observations over 26 pages at Lansing, Michigan.
- 2009–13Three Form 483s, at Lansing, Michigan.
- 2016–23Five Form 483s, at Lansing, Michigan.
Cited most
Across all Emergent Biodefense Operations Lansing observations on file
- 21 CFR 211.113Control of microbiological contamination21
- 21 CFR 211.192Production record review20
- 21 CFR 211.100Written procedures; deviations12
- 21 CFR 211.160General requirements6
- 21 CFR 211.22Responsibilities of quality control unit6
The complete Emergent Biodefense Operations Lansing file.
All 11 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
25% off buying them one by one
Sites
Lansing, Michigan
11 Form 483s · 2000 to 2023 · 97 observations
Latest: Form 483, Dec 13, 2023 →
Documents
11 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-12-13 | 483 Form 483 | Lansing, Michigan | 2 | $99 |
| 2021-09-29 | 483 Form 483 | Lansing, Michigan | 1 | $99 |
| 2019-10-04 | 483 Form 483 | Lansing, Michigan | 2 | $99 |
| 2018-09-27 | 483 Form 483 | Lansing, Michigan | 1 | $99 |
| 2016-04-19 | 483 Form 483 | Lansing, Michigan | 6 | $99 |
| 2013-11-14 | 483 Form 483 | Lansing, Michigan | 16 | $99 |
| 2011-09-09 | 483 Form 483 | Lansing, Michigan | 13 | $99 |
| 2009-12-10 | 483 Form 483 | Lansing, Michigan | 13 | $99 |
| 2002-09-13 | 483 Form 483 | Lansing, Michigan | — | $99 |
| 2000-10-26 | 483 Form 483 | Lansing, Michigan | 25 | $99 |
| 2000-10-26 | 483 Form 483 | Lansing, Michigan | 18 | $99 |
Investigators on these documents
Brentley Collins (2)Bruce D. Meade (1)Cynthia L. Kelley (1)Gene D. Arcy (1)Jacqueline Diaz-Albertini (1)Jay Eltermann (1)Jean Hu-Primmer (1)Julia Lukas Garman (1)Linda Thai (1)Ann M. Schofield (1)Myra K. Casey (1)
FEI number 1873886 · most recent document Dec 13, 2023
About Emergent Biodefense Operations Lansing LLC
How many FDA Form 483s has Emergent Biodefense Operations Lansing LLC received?
FDA Intel has 11 Form 483s on file for Emergent Biodefense Operations Lansing LLC; the most recent is dated Dec 13, 2023.
When was Emergent Biodefense Operations Lansing LLC last inspected by FDA?
The most recent FDA inspection document on file for Emergent Biodefense Operations Lansing LLC is a Form 483 dated Dec 13, 2023, for the site in Lansing, Michigan.
What did FDA cite at Emergent Biodefense Operations Lansing LLC?
The regulations cited most in the observations on file for Emergent Biodefense Operations Lansing LLC are 21 CFR 211.113 (Control of microbiological contamination), 21 times; 21 CFR 211.192 (Production record review), 20 times; 21 CFR 211.100 (Written procedures; deviations), 12 times.