Biobersa, Sa De Cv
⚠️ Moderate Risk
FEI: 3005955487 • Guadalajara, Jalisco • MEXICO
FEI Number
3005955487
Location
Guadalajara, Jalisco
Country
MEXICOAddress
Calle Efrain Gonzalez Luna No. 2007-25, Col. Obrera, Guadalajara, Guadalajara, Jalisco, Mexico
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 Biobersa, Sa De Cv's FDA import refusal history?
Biobersa, Sa De Cv (FEI: 3005955487) has 1 FDA import refusal record(s) in our database, spanning from 1/20/2011 to 1/20/2011.
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. Biobersa, Sa De Cv's FEI number is 3005955487.
What types of violations has Biobersa, Sa De Cv received?
Biobersa, Sa De Cv 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 Biobersa, Sa De Cv come from?
All FDA import refusal data for Biobersa, Sa De Cv 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.