Emergent Biodefense Operations Lansing LLC
FDA inspection history in Canton, Massachusetts, 2017 to 2023
- 2
- Form 483s
Every document, by year
- Form 483
2017: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017One Form 483, at Canton, Massachusetts.
- 2023One Form 483, at Canton, Massachusetts.
- 2023The longest 483 on file: 2 observations over 3 pages at Canton, Massachusetts.
Cited most
Across all Emergent Biodefense Operations Lansing observations on file
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.192Production record review2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 600.14Reporting of biological product deviations by licensed manufacturers2
- 21 CFR 211.160General requirements1
The complete Emergent Biodefense Operations Lansing file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Canton, Massachusetts
Two Form 483s · 2017 to 2023 · 2 observations
Latest: Form 483, Aug 16, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-08-16 | 483 Form 483 | Canton, Massachusetts | 2 | $99 |
| 2017-12-21 | 483 Form 483 | Canton, Massachusetts | — | $99 |
Investigators on these documents
FEI number 3004051669 · most recent document Aug 16, 2023
About Emergent Biodefense Operations Lansing LLC
How many FDA Form 483s has Emergent Biodefense Operations Lansing LLC received?
FDA Intel has 2 Form 483s on file for Emergent Biodefense Operations Lansing LLC; the most recent is dated Aug 16, 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 Aug 16, 2023, for the site in Canton, Massachusetts.
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), 2 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times.