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Kervie S.A Zona Franc

⚠️ Moderate Risk

FEI: 3007270352 • Montevideo Urugay • URUGUAY

FEI

FEI Number

3007270352

📍

Location

Montevideo Urugay

🇺🇾

Country

URUGUAY
🏢

Address

Zona Franca Montevideo, , Montevideo Urugay, , Uruguay

Moderate Risk

FDA Import Risk Assessment

30.1
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

6
Total Refusals
2
Unique Violations
4/5/2011
Latest Refusal
9/17/2010
Earliest Refusal

Score Breakdown

Violation Severity
36.7×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
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

3414×

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).

1182×

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).

Refusal History

DateProductViolationsDivision
4/5/2011
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
Division of Southeast Imports (DSEI)
4/5/2011
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
Division of Southeast Imports (DSEI)
9/17/2010
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Division of Southeast Imports (DSEI)
9/17/2010
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Division of Southeast Imports (DSEI)
9/17/2010
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Division of Southeast Imports (DSEI)
9/17/2010
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Kervie S.A Zona Franc's FDA import refusal history?

Kervie S.A Zona Franc (FEI: 3007270352) has 6 FDA import refusal record(s) in our database, spanning from 9/17/2010 to 4/5/2011.

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. Kervie S.A Zona Franc's FEI number is 3007270352.

What types of violations has Kervie S.A Zona Franc received?

Kervie S.A Zona Franc 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 Kervie S.A Zona Franc come from?

All FDA import refusal data for Kervie S.A Zona Franc 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.