Emergent Biodefense Operations Lansing LLC
Form 483 issued December 13, 2023 · Lansing, Michigan
- Inspection
- Dec 13, 2023
- Investigator
- Brentley Collins
- Observations
- 2
- Pages
- 3
- FEI number
- 1873886
In short: On December 13, 2023, FDA issued a Form 483 with 2 observations to Emergent Biodefense Operations Lansing LLC in Lansing, Michigan (FEI 1873886) after an inspection that ran Dec 13, 2023. The investigator was Brentley Collins. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.188 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Production records do not always contain information identifying | the equipment used…
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 211.192
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 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Emergent Biodefense Operations Lansing LLC?
Brentley Collins is named on this Form 483, for the inspection of Dec 13, 2023. Each investigator has a profile showing what they cite most.
When was Emergent Biodefense Operations Lansing LLC inspected by FDA?
The inspection ran Dec 13, 2023, and the Form 483 is dated December 13, 2023.
How do I get the full Form 483 for Emergent Biodefense Operations Lansing LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.