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Bristol Meyer S. De Mexico Sa Cv

⚠️ Moderate Risk

FEI: 3003118737 • Cd. Delicias Chihuahua • MEXICO

FEI

FEI Number

3003118737

📍

Location

Cd. Delicias Chihuahua

🇲🇽

Country

MEXICO
🏢

Address

Carr. Panamericana Km 1563, , Cd. Delicias Chihuahua, , Mexico

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
7/11/2006
Latest Refusal
7/11/2006
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

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
7/11/2006
60SBB09DIHYDROXYALUM SODIUM CARBONATE (ANTACID)
472NO ENGLISH
75UNAPPROVED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Bristol Meyer S. De Mexico Sa Cv's FDA import refusal history?

Bristol Meyer S. De Mexico Sa Cv (FEI: 3003118737) has 1 FDA import refusal record(s) in our database, spanning from 7/11/2006 to 7/11/2006.

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. Bristol Meyer S. De Mexico Sa Cv's FEI number is 3003118737.

What types of violations has Bristol Meyer S. De Mexico Sa Cv received?

Bristol Meyer S. De Mexico Sa Cv 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 Bristol Meyer S. De Mexico Sa Cv come from?

All FDA import refusal data for Bristol Meyer S. De Mexico Sa 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.