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Merck, Sharp And Dohme Farmaceut

⚠️ Moderate Risk

FEI: 3005593975 • Campinas • BRAZIL

FEI

FEI Number

3005593975

📍

Location

Campinas

🇧🇷

Country

BRAZIL
🏢

Address

Rue 13 De Idamo 1161, , Campinas, , Brazil

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
5/16/2013
Latest Refusal
5/16/2013
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
5/16/2013
62ODB28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Merck, Sharp And Dohme Farmaceut's FDA import refusal history?

Merck, Sharp And Dohme Farmaceut (FEI: 3005593975) has 1 FDA import refusal record(s) in our database, spanning from 5/16/2013 to 5/16/2013.

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. Merck, Sharp And Dohme Farmaceut's FEI number is 3005593975.

What types of violations has Merck, Sharp And Dohme Farmaceut received?

Merck, Sharp And Dohme Farmaceut 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 Merck, Sharp And Dohme Farmaceut come from?

All FDA import refusal data for Merck, Sharp And Dohme Farmaceut 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.