GELPHARMA S. A. DE C. V.
⚠️ High Risk
FEI: 3012429501 • Zapopan, Jalisco • MEXICO
FEI Number
3012429501
Location
Zapopan, Jalisco
Country
MEXICOAddress
Calle Madero NO 5908, Pueblo Jocotan, Zapopan, Jalisco, Mexico
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/3/2025 | 62GCY41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/10/2025 | 54AFY99VITAMIN, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/28/2017 | 62GCY41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/3/2017 | 62ACF04CALCITRIOL (ANTI-HYPERCALCEMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/24/2017 | 66SCY27NIFEDIPINE (VASODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/22/2017 | 62GAC41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is GELPHARMA S. A. DE C. V.'s FDA import refusal history?
GELPHARMA S. A. DE C. V. (FEI: 3012429501) has 6 FDA import refusal record(s) in our database, spanning from 2/22/2017 to 12/3/2025.
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. GELPHARMA S. A. DE C. V.'s FEI number is 3012429501.
What types of violations has GELPHARMA S. A. DE C. V. received?
GELPHARMA 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 GELPHARMA S. A. DE C. V. come from?
All FDA import refusal data for GELPHARMA 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.