Pfizer Clinical Research Unit, Hopital Erasme
✅ Low Risk
FEI: 3007000232 • Anderlecht, Brussels-Capital Region • BELGIUM
FEI Number
3007000232
Location
Anderlecht, Brussels-Capital Region
Country
BELGIUMAddress
Lennikse Baan 808, , Anderlecht, Brussels-Capital Region, Belgium
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
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).
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
Frequently Asked Questions
What is Pfizer Clinical Research Unit, Hopital Erasme's FDA import refusal history?
Pfizer Clinical Research Unit, Hopital Erasme (FEI: 3007000232) has 1 FDA import refusal record(s) in our database, spanning from 8/31/2009 to 8/31/2009.
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. Pfizer Clinical Research Unit, Hopital Erasme's FEI number is 3007000232.
What types of violations has Pfizer Clinical Research Unit, Hopital Erasme received?
Pfizer Clinical Research Unit, Hopital Erasme 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 Pfizer Clinical Research Unit, Hopital Erasme come from?
All FDA import refusal data for Pfizer Clinical Research Unit, Hopital Erasme 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.