Emergent BioSolutions Canada Inc.
Form 483 issued May 16, 2017 · Winnipeg, Canada
- Inspection
- May 8 – May 16, 2017
- Investigator
- Prabhu P. Raju
- Observations
- 4
- Pages
- 5
- FEI number
- 3003153579
In short: On May 16, 2017, FDA issued a Form 483 with 4 observations to Emergent BioSolutions Canada Inc. in Winnipeg, Manitoba (FEI 3003153579) after an inspection that ran May 8 – May 16, 2017. The investigator was Prabhu P. Raju. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.46 (ventilation, air filtration, air heating and cooling).
At a glance
Observations span 2 systems, led by facilities & equipment.
Most cited: 21 CFR 211.46 (1×) · 211.110 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding air handling systems that maintain air quality. The firm has…
- 02
(b) (4) controls to prevent the inclusion of…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Specifications established during Process validations are inadequate…
This inspection in context
Prabhu P. Raju
21 documents · 2008–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in France.
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 211.46
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Emergent BioSolutions Canada Inc.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.46 (ventilation, air filtration, air heating and cooling). The opening words of each observation are shown on this page.
Who inspected Emergent BioSolutions Canada Inc.?
Prabhu P. Raju is named on this Form 483, for the inspection of May 8 – May 16, 2017. Each investigator has a profile showing what they cite most.
When was Emergent BioSolutions Canada Inc. inspected by FDA?
The inspection ran May 8 – May 16, 2017, and the Form 483 is dated May 16, 2017.
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.