Emergent Biodefense Operations Lansing LLC
Form 483 issued September 9, 2011 · Lansing, Michigan
- Inspection
- Aug 30 – Sep 9, 2011
- Observations
- 13
- Pages
- 7
- FEI number
- 1873886
In short: On September 9, 2011, FDA issued a Form 483 with 13 observations to Emergent Biodefense Operations Lansing LLC in Lansing, Michigan (FEI 1873886) after an inspection that ran Aug 30 – Sep 9, 2011.
What FDA observed
Preview: the opening words of each observation- 01
Authorization to deviate from an approved process…
- 02
Qualification of raw material from new and…
- 03
The assessment performed in response to a previous FDA 483 observation, regarding the lack of data…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Questions about this 483
What did FDA find at Emergent Biodefense Operations Lansing LLC?
FDA listed 13 observations on this Form 483. The opening words of each observation are shown on this page.
When was Emergent Biodefense Operations Lansing LLC inspected by FDA?
The inspection ran Aug 30 – Sep 9, 2011, and the Form 483 is dated September 9, 2011.
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.