Bergottini & Weyer Group
✅ Low Risk
FEI: 3003854317 • Buenos Aires • ARGENTINA
FEI Number
3003854317
Location
Buenos Aires
Country
ARGENTINAAddress
Riobamba 965, , Buenos Aires, , Argentina
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
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 Bergottini & Weyer Group's FDA import refusal history?
Bergottini & Weyer Group (FEI: 3003854317) has 2 FDA import refusal record(s) in our database, spanning from 12/13/2002 to 12/13/2002.
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. Bergottini & Weyer Group's FEI number is 3003854317.
What types of violations has Bergottini & Weyer Group received?
Bergottini & Weyer Group has been cited for 1 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 Bergottini & Weyer Group come from?
All FDA import refusal data for Bergottini & Weyer Group 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.