Emergent Biodefense Operations Lansing LLC
Form 483 issued December 21, 2017 · Canton, Massachusetts
- Inspection
- Dec 15 – Dec 21, 2017
- Investigator
- Debra M. Emerson
- Observations
- 10
- Pages
- 4
- FEI number
- 3004051669
In short: On December 21, 2017, FDA issued a Form 483 with 10 observations to Emergent Biodefense Operations Lansing LLC in Canton, Massachusetts (FEI 3004051669) after an inspection that ran Dec 15 – Dec 21, 2017. The investigator was Debra M. Emerson. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 600.14 (reporting of biological product deviations by licensed manufacturers).
At a glance
Facilities & equipment and quality system account for 6 of 10 observations.
Most cited: 21 CFR 600.14 (2×) · 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The following deviations were noted during review of the Biological…
- 02
The firm has not implemented any corrective actions in response to low level mold and yeast…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Investigations are not always…
This inspection in context
Debra M. Emerson
27 documents · 2008–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Massachusetts.
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 600.14
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 10 observations on this Form 483, mostly about facilities & equipment, quality system and biologics CGMP. The most-cited regulation is 21 CFR 600.14 (reporting of biological product deviations by licensed manufacturers). The opening words of each observation are shown on this page.
Who inspected Emergent Biodefense Operations Lansing LLC?
Debra M. Emerson is named on this Form 483, for the inspection of Dec 15 – Dec 21, 2017. Each investigator has a profile showing what they cite most.
When was Emergent Biodefense Operations Lansing LLC inspected by FDA?
The inspection ran Dec 15 – Dec 21, 2017, and the Form 483 is dated December 21, 2017.
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.