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Merck Laboratories Sa De Cv

⚠️ Moderate Risk

FEI: 3005771127 • Mexico City • MEXICO

FEI

FEI Number

3005771127

📍

Location

Mexico City

🇲🇽

Country

MEXICO
🏢

Address

Colonia Insurgentes, , Mexico City, , Mexico

Moderate Risk

FDA Import Risk Assessment

44.6
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
10/11/2013
Latest Refusal
3/30/2012
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
19.6×10%
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

753×

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
10/11/2013
66VCA99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/11/2013
66VCA99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)
3/30/2012
66JCB01LEVOTHYROXINE SODIUM (THYROID HORMONE)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Merck Laboratories Sa De Cv's FDA import refusal history?

Merck Laboratories Sa De Cv (FEI: 3005771127) has 3 FDA import refusal record(s) in our database, spanning from 3/30/2012 to 10/11/2013.

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 Laboratories Sa De Cv's FEI number is 3005771127.

What types of violations has Merck Laboratories Sa De Cv received?

Merck Laboratories Sa De Cv 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 Laboratories Sa De Cv come from?

All FDA import refusal data for Merck Laboratories Sa De Cv 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.