Emergent Biodefense Operations Lansing LLC
Form 483 issued November 14, 2013 · Lansing, Michigan
- Inspection
- Nov 5 – Nov 14, 2013
- Observations
- 16
- Pages
- 8
- FEI number
- 1873886
In short: On November 14, 2013, FDA issued a Form 483 with 16 observations to Emergent Biodefense Operations Lansing LLC in Lansing, Michigan (FEI 1873886) after an inspection that ran Nov 5 – Nov 14, 2013. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 12 of 16 observations.
Most cited: 21 CFR 211.113 (3×) · 211.192 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Environmental monitoring is…
- 02
QC Methods are not always adequately validated for their intended use as described in SOP 10000001…
- 03
Although the firm has been conducting activities to address recurring QGP rotcin and SDS-PAGE 00S results…
- 04
The current procedure to track recurring system suitability test (SST) failures which occurred during the phemerol…
This inspection in context
Questions about this 483
What did FDA find at Emergent Biodefense Operations Lansing LLC?
FDA listed 16 observations on this Form 483, mostly about production, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
When was Emergent Biodefense Operations Lansing LLC inspected by FDA?
The inspection ran Nov 5 – Nov 14, 2013, and the Form 483 is dated November 14, 2013.
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.