Emergent BioSolutions Canada Inc.
FDA inspection history in Winnipeg, Canada, 2012 to 2022
- 5
- Form 483s
- 1
- EIR
Every document, by year
- Form 483
- EIR
2012: one Form 483; 2014: one Form 483; 2017: one Form 483; 2019: one inspection report and one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2012–14Two Form 483s, at Winnipeg, Canada.
- 2012The longest 483 on file: 10 observations over 5 pages at Winnipeg, Canada.
- 2017–19Two Form 483s and one inspection report, at Winnipeg, Canada.
- 2022One Form 483, at Winnipeg, Canada.
Cited most
Across all Emergent BioSolutions Canada observations on file
- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 211.192Production record review3
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products2
- 21 CFR 211.160General requirements2
The complete Emergent BioSolutions Canada file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Winnipeg, Canada
Five Form 483s · 2012 to 2022 · 15 observations
Latest: Form 483, May 10, 2022 →
Also: one document not tied to a site.
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-05-10 | 483 Form 483 | Winnipeg, Canada | — | $99 |
| 2019-09-13 | EIR EIR | — | — | $550 |
| 2019-09-13 | 483 Form 483 | Winnipeg, Canada | 1 | $99 |
| 2017-05-16 | 483 Form 483 | Winnipeg, Canada | 4 | $99 |
| 2014-07-18 | 483 Form 483 | Winnipeg, Canada | — | $99 |
| 2012-06-21 | 483 Form 483 | Winnipeg, Canada | 10 | $99 |
Investigators on these documents
Aes Ie (1)Jonathan G. Matrisciano (1)Linda Thai (1)Prabhu P. Raju (1)
FEI number 3003153579 · most recent document May 10, 2022
About Emergent BioSolutions Canada Inc.
How many FDA Form 483s has Emergent BioSolutions Canada Inc. received?
FDA Intel has 5 Form 483s on file for Emergent BioSolutions Canada Inc.; the most recent is dated May 10, 2022.
When was Emergent BioSolutions Canada Inc. last inspected by FDA?
The most recent FDA inspection document on file for Emergent BioSolutions Canada Inc. is a Form 483 dated May 10, 2022, for the site in Winnipeg, Canada.
What did FDA cite at Emergent BioSolutions Canada Inc.?
The regulations cited most in the observations on file for Emergent BioSolutions Canada Inc. are 21 CFR 211.113 (Control of microbiological contamination), 5 times; 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.100 (Written procedures; deviations), 2 times.