Seqirus Vaccines Limited
⚠️ High Risk
FEI: 3002806949 • Liverpool, LIV • UNITED KINGDOM
FEI Number
3002806949
Location
Liverpool, LIV
Country
UNITED KINGDOMAddress
Gaskill Road, Liv, Liverpool, LIV, United Kingdom
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
NO LICENSE
The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/18/2025 | 57CI02INFLUENZA VIRUS VACCINE | 71NO LICENSE | Division of Southeast Imports (DSEI) |
| 8/18/2025 | 57CI02INFLUENZA VIRUS VACCINE | 71NO LICENSE | Division of Southeast Imports (DSEI) |
| 8/18/2025 | 57CI02INFLUENZA VIRUS VACCINE | 71NO LICENSE | Division of Southeast Imports (DSEI) |
| 4/30/2025 | 57CI02INFLUENZA VIRUS VACCINE | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/24/2024 | 57CI02INFLUENZA VIRUS VACCINE | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 9/26/2003 | 57CY02INFLUENZA VIRUS VACCINE | 27DRUG GMPS | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Seqirus Vaccines Limited's FDA import refusal history?
Seqirus Vaccines Limited (FEI: 3002806949) has 6 FDA import refusal record(s) in our database, spanning from 9/26/2003 to 8/18/2025.
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. Seqirus Vaccines Limited's FEI number is 3002806949.
What types of violations has Seqirus Vaccines Limited received?
Seqirus Vaccines Limited has been cited for 2 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 Seqirus Vaccines Limited come from?
All FDA import refusal data for Seqirus Vaccines Limited 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.