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NOVARTIS BIOCI NCIAS S/A

✅ Low Risk

FEI: 3013514790 • Sao Paulo, Sao Paulo • BRAZIL

FEI

FEI Number

3013514790

📍

Location

Sao Paulo, Sao Paulo

🇧🇷

Country

BRAZIL
🏢

Address

Avenida Ceci 1800 Lt 04, , Sao Paulo, Sao Paulo, Brazil

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
6/29/2017
Latest Refusal
6/29/2017
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

1181×

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).

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
6/29/2017
86LYLACCESSORIES TO CONTACT LENS SOLUTION
118NOT LISTED
3280FRNMFGREG
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is NOVARTIS BIOCI NCIAS S/A's FDA import refusal history?

NOVARTIS BIOCI NCIAS S/A (FEI: 3013514790) has 1 FDA import refusal record(s) in our database, spanning from 6/29/2017 to 6/29/2017.

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. NOVARTIS BIOCI NCIAS S/A's FEI number is 3013514790.

What types of violations has NOVARTIS BIOCI NCIAS S/A received?

NOVARTIS BIOCI NCIAS S/A 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 NOVARTIS BIOCI NCIAS S/A come from?

All FDA import refusal data for NOVARTIS BIOCI NCIAS S/A 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.