Emergent BioSolutions Canada Inc.
Form 483 issued June 21, 2012 · Winnipeg, Canada
- Inspection
- Jun 12 – Jun 21, 2012
- Observations
- 10
- Pages
- 5
- FEI number
- 3003153579
In short: On June 21, 2012, FDA issued a Form 483 with 10 observations to Emergent BioSolutions Canada Inc. in Winnipeg, Manitoba (FEI 3003153579) after an inspection that ran Jun 12 – Jun 21, 2012. 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 6 of 10 observations.
Most cited: 21 CFR 211.192 (2×) · 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The firm's investigation into (b)(4) process interruptions for VIGIV bulk lots (b)(4)…
- 02
There are no individual reject rates established for each defect category that is classified as (b)(4)…
- 03
Not all lots of product that fail the Acceptable Quality Limit (AQL) after the initial (b)(4)…
- 04
There is a lack of assurance that there is adequate control over critical documents including, but…
This inspection in context
Questions about this 483
What did FDA find at Emergent BioSolutions Canada Inc.?
FDA listed 10 observations on this Form 483, mostly about production, quality system and facilities & equipment. 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 BioSolutions Canada Inc. inspected by FDA?
The inspection ran Jun 12 – Jun 21, 2012, and the Form 483 is dated June 21, 2012.
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.