Emergent Biodefense Operations Lansing LLC
Form 483 issued September 27, 2018 · Lansing, Michigan
- Inspection
- Sep 20 – Sep 27, 2018
- Investigators
- Gene D. Arcy· Jean Hu-Primmer
- Observations
- 5
- Pages
- 5
- FEI number
- 1873886
In short: On September 27, 2018, FDA issued a Form 483 with 5 observations to Emergent Biodefense Operations Lansing LLC in Lansing, Michigan (FEI 1873886) after an inspection that ran Sep 20 – Sep 27, 2018. The investigators were Gene D. Arcy and Jean Hu-Primmer. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
4 of 5 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (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 responsibilities and procedures applicable to the quality control unit are not in…
- 02
There is no assurance that work orders are being reviewed by…
- 03
Deviation 3100004479 (still open) addresses organisms (Bacillus anthracis) detected in a filtrate sample post sterile filtration…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Gene D. Arcy
16 documents · 2003–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
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 211.22
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 5 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Emergent Biodefense Operations Lansing LLC?
Gene D. Arcy and Jean Hu-Primmer are named on this Form 483, for the inspection of Sep 20 – Sep 27, 2018. Each investigator has a profile showing what they cite most.
When was Emergent Biodefense Operations Lansing LLC inspected by FDA?
The inspection ran Sep 20 – Sep 27, 2018, and the Form 483 is dated September 27, 2018.
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.