ThermoFisher Scientific
⚠️ Moderate Risk
FEI: 3002807840 • Basingstoke, Hampshire • UNITED KINGDOM
FEI Number
3002807840
Location
Basingstoke, Hampshire
Country
UNITED KINGDOMAddress
Wade Road, , Basingstoke, Hampshire, United Kingdom
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
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.
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/16/2011 | 56CCS69CEFTIZOXIME SODIUM (CEPHALOSPORINS) | Chicago District Office (CHI-DO) | |
| 6/21/2007 | 83GQNANTIGEN, CF (INCLUDING CF CONTROL), HERPESVIRUS HOMINIS 1,2 | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 6/21/2007 | 83GQNANTIGEN, CF (INCLUDING CF CONTROL), HERPESVIRUS HOMINIS 1,2 | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 6/21/2007 | 83GQNANTIGEN, CF (INCLUDING CF CONTROL), HERPESVIRUS HOMINIS 1,2 | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is ThermoFisher Scientific's FDA import refusal history?
ThermoFisher Scientific (FEI: 3002807840) has 4 FDA import refusal record(s) in our database, spanning from 6/21/2007 to 2/16/2011.
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. ThermoFisher Scientific's FEI number is 3002807840.
What types of violations has ThermoFisher Scientific received?
ThermoFisher Scientific has been cited for 3 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 ThermoFisher Scientific come from?
All FDA import refusal data for ThermoFisher Scientific 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.