Emergent BioSolutions Canada Inc.
Form 483 issued July 18, 2014 · Winnipeg, Canada
- Inspection
- Jul 9 – Jul 18, 2014
- Investigator
- Aes Ie
- Observations
- 5
- Pages
- 8
- FEI number
- 3003153579
In short: On July 18, 2014, FDA issued a Form 483 with 5 observations to Emergent BioSolutions Canada Inc. in Winnipeg, Manitoba (FEI 3003153579) after an inspection that ran Jul 9 – Jul 18, 2014. The investigator was Aes Ie. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
3 of 5 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
Failure to conduct investigations…
- 02
Appropriate written procedures, including validation designed to prevent Se (b)(4) of products purporting to be sterile…
- 03
The following visual observations were made during the inspection: A. On 7/ 10/14, in the basement…
- 04
Media simulation studies are…
This inspection in context
Aes Ie
1 document · 2014
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Canada.
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 5 observations on this Form 483, mostly about production, quality system and facilities & equipment. 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.?
Aes Ie is named on this Form 483, for the inspection of Jul 9 – Jul 18, 2014. Each investigator has a profile showing what they cite most.
When was Emergent BioSolutions Canada Inc. inspected by FDA?
The inspection ran Jul 9 – Jul 18, 2014, and the Form 483 is dated July 18, 2014.
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.