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GELCAPS EXPORTADORA DE MEXICO SA

⚠️ Moderate Risk

FEI: 3013292895 • Col Del Vale c.p. 031 • MEXICO

FEI

FEI Number

3013292895

📍

Location

Col Del Vale c.p. 031

🇲🇽

Country

MEXICO
🏢

Address

Nicolas San Juan 1046 C, , Col Del Vale c.p. 031, , Mexico

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
3/23/2017
Latest Refusal
3/23/2017
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

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
3/23/2017
61KDA99ANTI-CHOLINERGIC, N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is GELCAPS EXPORTADORA DE MEXICO SA's FDA import refusal history?

GELCAPS EXPORTADORA DE MEXICO SA (FEI: 3013292895) has 1 FDA import refusal record(s) in our database, spanning from 3/23/2017 to 3/23/2017.

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. GELCAPS EXPORTADORA DE MEXICO SA's FEI number is 3013292895.

What types of violations has GELCAPS EXPORTADORA DE MEXICO SA received?

GELCAPS EXPORTADORA DE MEXICO SA 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 GELCAPS EXPORTADORA DE MEXICO SA come from?

All FDA import refusal data for GELCAPS EXPORTADORA DE MEXICO SA 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.