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Laboratorios Stiefel Ltda

⚠️ Moderate Risk

FEI: 3006549379 • Guarulhos • BRAZIL

FEI

FEI Number

3006549379

📍

Location

Guarulhos

🇧🇷

Country

BRAZIL
🏢

Address

63.064.653/0003-16, , Guarulhos, , Brazil

Moderate Risk

FDA Import Risk Assessment

28.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
6/5/2009
Latest Refusal
6/5/2009
Earliest Refusal

Score Breakdown

Violation Severity
47.5×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

1183×

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).

3351×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

Refusal History

DateProductViolationsDivision
6/5/2009
65LBK99PROTECTANT N.E.C.
118NOT LISTED
335LACKS N/C
New Orleans District Office (NOL-DO)
6/5/2009
65LBK99PROTECTANT N.E.C.
118NOT LISTED
New Orleans District Office (NOL-DO)
6/5/2009
65LBK99PROTECTANT N.E.C.
118NOT LISTED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Laboratorios Stiefel Ltda's FDA import refusal history?

Laboratorios Stiefel Ltda (FEI: 3006549379) has 3 FDA import refusal record(s) in our database, spanning from 6/5/2009 to 6/5/2009.

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. Laboratorios Stiefel Ltda's FEI number is 3006549379.

What types of violations has Laboratorios Stiefel Ltda received?

Laboratorios Stiefel Ltda 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 Laboratorios Stiefel Ltda come from?

All FDA import refusal data for Laboratorios Stiefel Ltda 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.