Emergent BioSolutions Canada Inc.
Form 483 issued May 10, 2022 · Winnipeg, Canada
- Inspection
- May 2 – May 10, 2022
- Investigator
- Linda Thai
- Observations
- 3
- Pages
- 3
- FEI number
- 3003153579
In short: On May 10, 2022, FDA issued a Form 483 with 3 observations to Emergent BioSolutions Canada Inc. in Winnipeg, Manitoba (FEI 3003153579) after an inspection that ran May 2 – May 10, 2022. The investigator was Linda Thai. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
2 of 3 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (2×)
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 microbial contamination of drug products purporting to…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Laboratory procedures for the control of…
This inspection in context
Linda Thai
18 documents · 2014–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
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 3 observations on this Form 483, mostly about production 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.
Who inspected Emergent BioSolutions Canada Inc.?
Linda Thai is named on this Form 483, for the inspection of May 2 – May 10, 2022. Each investigator has a profile showing what they cite most.
When was Emergent BioSolutions Canada Inc. inspected by FDA?
The inspection ran May 2 – May 10, 2022, and the Form 483 is dated May 10, 2022.
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.