Emergent BioSolutions Canada Inc.
⚠️ Moderate Risk
FEI: 3003153579 • Winnipeg, Manitoba • CANADA
FEI Number
3003153579
Location
Winnipeg, Manitoba
Country
CANADAAddress
155 Innovation Dr, , Winnipeg, Manitoba, Canada
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/25/2023 | 57CL33COVID 19 VACCINE | 237NO PMA | Division of Southeast Imports (DSEI) |
| 2/26/2021 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | Division of Southeast Imports (DSEI) | |
| 6/3/2013 | 79KGXTAPE AND BANDAGE, ADHESIVE | New Orleans District Office (NOL-DO) | |
| 6/3/2013 | 79KGOSURGEON'S GLOVES | New Orleans District Office (NOL-DO) | |
| 5/7/2007 | 55YP99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 5/7/2007 | 55YP99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 5/7/2007 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 5/7/2007 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 5/7/2007 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is Emergent BioSolutions Canada Inc.'s FDA import refusal history?
Emergent BioSolutions Canada Inc. (FEI: 3003153579) has 9 FDA import refusal record(s) in our database, spanning from 5/7/2007 to 4/25/2023.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Emergent BioSolutions Canada Inc.'s FEI number is 3003153579.
What types of violations has Emergent BioSolutions Canada Inc. received?
Emergent BioSolutions Canada Inc. has been cited for 6 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Emergent BioSolutions Canada Inc. come from?
All FDA import refusal data for Emergent BioSolutions Canada Inc. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.