3B OPTIC INSTRUMENTS SA DE ERIC G SCHELLHAS
✅ Low Risk
FEI: 3007041830 • Rosario, Santa Fe • ARGENTINA
FEI Number
3007041830
Location
Rosario, Santa Fe
Country
ARGENTINAAddress
Calle Ocampo 370, , Rosario, Santa Fe, 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
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 3B OPTIC INSTRUMENTS SA DE ERIC G SCHELLHAS's FDA import refusal history?
3B OPTIC INSTRUMENTS SA DE ERIC G SCHELLHAS (FEI: 3007041830) has 1 FDA import refusal record(s) in our database, spanning from 8/20/2008 to 8/20/2008.
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. 3B OPTIC INSTRUMENTS SA DE ERIC G SCHELLHAS's FEI number is 3007041830.
What types of violations has 3B OPTIC INSTRUMENTS SA DE ERIC G SCHELLHAS received?
3B OPTIC INSTRUMENTS SA DE ERIC G SCHELLHAS 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 3B OPTIC INSTRUMENTS SA DE ERIC G SCHELLHAS come from?
All FDA import refusal data for 3B OPTIC INSTRUMENTS SA DE ERIC G SCHELLHAS 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.