Emergent Biodefense Operations Lansing LLC
Form 483 issued August 16, 2023 · Canton, Massachusetts
- Inspection
- Aug 7 – Aug 16, 2023
- Investigator
- Shafiq S. Ahadi
- Observations
- 2
- Pages
- 3
- FEI number
- 3004051669
In short: On August 16, 2023, FDA issued a Form 483 with 2 observations to Emergent Biodefense Operations Lansing LLC in Canton, Massachusetts (FEI 3004051669) after an inspection that ran Aug 7 – Aug 16, 2023. The investigator was Shafiq S. Ahadi. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.180 (general requirements).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.180 (1×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Records associated with investigations into deviations of drug substance manufacturing and within the retention period for…
- 02
Aseptic Process Simulation studies do not simulate…
This inspection in context
Shafiq S. Ahadi
7 documents · 2016–2025
Cites 820.30(b) (design controls) more than any other section. Most of their documents are for sites in Illinois.
The firmEmergent Biodefense Operations Lansing LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.180
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 2 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.180 (general requirements). The opening words of each observation are shown on this page.
Who inspected Emergent Biodefense Operations Lansing LLC?
Shafiq S. Ahadi is named on this Form 483, for the inspection of Aug 7 – Aug 16, 2023. Each investigator has a profile showing what they cite most.
When was Emergent Biodefense Operations Lansing LLC inspected by FDA?
The inspection ran Aug 7 – Aug 16, 2023, and the Form 483 is dated August 16, 2023.
How do I get the full Form 483 for Emergent Biodefense Operations Lansing LLC?
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