Bio Serae Laboratoires
⚠️ Moderate Risk
FEI: 3002684070 • Montolieu, Aude • FRANCE
FEI Number
3002684070
Location
Montolieu, Aude
Country
FRANCEAddress
BP 6, Las Tapios, Montolieu, Aude, France
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
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
Frequently Asked Questions
What is Bio Serae Laboratoires's FDA import refusal history?
Bio Serae Laboratoires (FEI: 3002684070) has 1 FDA import refusal record(s) in our database, spanning from 3/25/2005 to 3/25/2005.
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. Bio Serae Laboratoires's FEI number is 3002684070.
What types of violations has Bio Serae Laboratoires received?
Bio Serae Laboratoires 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 Bio Serae Laboratoires come from?
All FDA import refusal data for Bio Serae Laboratoires 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.