Emergent Biodefense Operations Lansing LLC
Form 483 issued September 29, 2021 · Lansing, Michigan
- Inspection
- Sep 21 – Sep 29, 2021
- Investigators
- Brentley Collins· Linda Thai
- Observations
- 1
- Pages
- 3
- FEI number
- 1873886
In short: On September 29, 2021, FDA issued a Form 483 with 1 observation to Emergent Biodefense Operations Lansing LLC in Lansing, Michigan (FEI 1873886) after an inspection that ran Sep 21 – Sep 29, 2021. The investigators were Brentley Collins and Linda Thai. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.170 (reserve samples).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.170(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Reserve drug product samples are not representative of each lot or…
This inspection in context
Brentley Collins
11 documents · 2019–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Massachusetts.
The firmEmergent Biodefense Operations Lansing LLC history
All 11 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.170(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Emergent Biodefense Operations Lansing LLC?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.170 (reserve samples). The opening words of each observation are shown on this page.
Who inspected Emergent Biodefense Operations Lansing LLC?
Brentley Collins and Linda Thai are named on this Form 483, for the inspection of Sep 21 – Sep 29, 2021. Each investigator has a profile showing what they cite most.
When was Emergent Biodefense Operations Lansing LLC inspected by FDA?
The inspection ran Sep 21 – Sep 29, 2021, and the Form 483 is dated September 29, 2021.
How do I get the full Form 483 for Emergent Biodefense Operations Lansing LLC?
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