Emergent Biodefense Operations Lansing LLC
Form 483 issued April 19, 2016 · Lansing, Michigan
- Inspection
- Apr 12 – Apr 19, 2016
- Observations
- 6
- Pages
- 2
- FEI number
- 1873886
In short: On April 19, 2016, FDA issued a Form 483 with 6 observations to Emergent Biodefense Operations Lansing LLC in Lansing, Michigan (FEI 1873886) after an inspection that ran Apr 12 – Apr 19, 2016. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Production and quality system account for 5 of 6 observations.
Most cited: 21 CFR 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
Nonconformance Event (NCE) 70007710, dated 1127/2016, (Building(b)(4) Room(b)(4) ), Chest Atypical Mold, reported 1 cfu of…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Observation 3: scanned text, readable in the full document.
- 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 6 observations on this Form 483, mostly about production, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was Emergent Biodefense Operations Lansing LLC inspected by FDA?
The inspection ran Apr 12 – Apr 19, 2016, and the Form 483 is dated April 19, 2016.
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.