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Coyoacan Quimica, S.A. De C.V.

⚠️ Moderate Risk

FEI: 3003467881 • San Luis Potosi • MEXICO

FEI

FEI Number

3003467881

📍

Location

San Luis Potosi

🇲🇽

Country

MEXICO
🏢

Address

Carret. Central Km. 419.1 Zona, , San Luis Potosi, , Mexico

Moderate Risk

FDA Import Risk Assessment

38.0
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
5/9/2012
Latest Refusal
4/2/2009
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
6.4×10%
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

1151×

DR QUALITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.

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
5/9/2012
60SAU13MAGNESIUM CARBONATE (ANTACID)
115DR QUALITY
Southwest Import District Office (SWI-DO)
4/2/2009
60SAY13MAGNESIUM CARBONATE (ANTACID)
75UNAPPROVED
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

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

Coyoacan Quimica, S.A. De C.V. (FEI: 3003467881) has 2 FDA import refusal record(s) in our database, spanning from 4/2/2009 to 5/9/2012.

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. Coyoacan Quimica, S.A. De C.V.'s FEI number is 3003467881.

What types of violations has Coyoacan Quimica, S.A. De C.V. received?

Coyoacan Quimica, S.A. De C.V. 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 Coyoacan Quimica, S.A. De C.V. come from?

All FDA import refusal data for Coyoacan Quimica, 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.