Emergent Biodefense Operations Lansing LLC
Form 483 issued December 10, 2009 · Lansing, Michigan
- Inspection
- Dec 1 – Dec 10, 2009
- Observations
- 13
- Pages
- 6
- FEI number
- 1873886
In short: On December 10, 2009, FDA issued a Form 483 with 13 observations to Emergent Biodefense Operations Lansing LLC in Lansing, Michigan (FEI 1873886) after an inspection that ran Dec 1 – Dec 10, 2009. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.160 (2×) · 211.100 (2×)
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
Quality Unit oversight is not required for all…
- 03
Failure to thoroughly investigate any unexplained discrepancy of a batch or any of its components to…
- 04
There are no data to support all expiry dates assigned to those raw materials and/or reagents/standards/…
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, mostly about production, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was Emergent Biodefense Operations Lansing LLC inspected by FDA?
The inspection ran Dec 1 – Dec 10, 2009, and the Form 483 is dated December 10, 2009.
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.