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MERCK BIOPHARMA

⚠️ Moderate Risk

FEI: 3018317367 • Cuautitla • MEXICO

FEI

FEI Number

3018317367

📍

Location

Cuautitla

🇲🇽

Country

MEXICO
🏢

Address

Hall 3 Int 3a R Km 34.5, , Cuautitla, , Mexico

Moderate Risk

FDA Import Risk Assessment

29.4
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
4/21/2021
Latest Refusal
4/21/2021
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
5.5×20%
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

33401×

DE/RX KIT

The article appears to be a combination medical device/prescription drug kit for which the prescription drug component was manufactured in the U.S., is offered for import by other than the manufacturer, and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.

Refusal History

DateProductViolationsDivision
4/21/2021
61CDA99ANTI-ANEMIC, N.E.C.
3340DE/RX KIT
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is MERCK BIOPHARMA's FDA import refusal history?

MERCK BIOPHARMA (FEI: 3018317367) has 1 FDA import refusal record(s) in our database, spanning from 4/21/2021 to 4/21/2021.

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 BIOPHARMA's FEI number is 3018317367.

What types of violations has MERCK BIOPHARMA received?

MERCK BIOPHARMA 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 BIOPHARMA come from?

All FDA import refusal data for MERCK BIOPHARMA 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.