Emergent BioSolutions Canada Inc.
Form 483 issued September 13, 2019 · Winnipeg, Canada
- Inspection
- Sep 5 – Sep 13, 2019
- Investigator
- Jonathan G. Matrisciano
- Observations
- 1
- Pages
- 1
- FEI number
- 3003153579
In short: On September 13, 2019, FDA issued a Form 483 with 1 observation to Emergent BioSolutions Canada Inc. in Winnipeg, Canada (FEI 3003153579) after an inspection that ran Sep 5 – Sep 13, 2019. The investigator was Jonathan G. Matrisciano. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
Jonathan G. Matrisciano
29 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Massachusetts.
The firmEmergent BioSolutions Canada Inc. history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Emergent BioSolutions Canada Inc.?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Emergent BioSolutions Canada Inc.?
Jonathan G. Matrisciano is named on this Form 483, for the inspection of Sep 5 – Sep 13, 2019. Each investigator has a profile showing what they cite most.
When was Emergent BioSolutions Canada Inc. inspected by FDA?
The inspection ran Sep 5 – Sep 13, 2019, and the Form 483 is dated September 13, 2019.
How do I get the full Form 483 for Emergent BioSolutions Canada Inc.?
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.