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Unipharm De Mexico, S.A. De C.V.

⚠️ Moderate Risk

FEI: 3003181060 • Veracruz, Veracruz de Ignacio de La Llav • MEXICO

FEI

FEI Number

3003181060

📍

Location

Veracruz, Veracruz de Ignacio de La Llav

🇲🇽

Country

MEXICO
🏢

Address

Tamarindos Xv-A Lote 10, , Veracruz, Veracruz de Ignacio de La Llav, Mexico

Moderate Risk

FDA Import Risk Assessment

42.4
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
7/25/2008
Latest Refusal
8/29/2006
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
10.5×10%
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

752×

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
7/25/2008
66VCA99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
8/29/2006
61FBB56CLARITHROMYCIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Unipharm De Mexico, S.A. De C.V.'s FDA import refusal history?

Unipharm De Mexico, S.A. De C.V. (FEI: 3003181060) has 2 FDA import refusal record(s) in our database, spanning from 8/29/2006 to 7/25/2008.

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. Unipharm De Mexico, S.A. De C.V.'s FEI number is 3003181060.

What types of violations has Unipharm De Mexico, S.A. De C.V. received?

Unipharm De Mexico, S.A. De C.V. 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 Unipharm De Mexico, S.A. De C.V. come from?

All FDA import refusal data for Unipharm De Mexico, S.A. De C.V. 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.