GELCAPS EXPORTADORA DE MEXICO
⚠️ Moderate Risk
FEI: 3012451201 • Naucalpan • MEXICO
FEI Number
3012451201
Location
Naucalpan
Country
MEXICOAddress
Cto Centro Civico NO 27, , Naucalpan, , Mexico
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
Frequently Asked Questions
What is GELCAPS EXPORTADORA DE MEXICO's FDA import refusal history?
GELCAPS EXPORTADORA DE MEXICO (FEI: 3012451201) has 3 FDA import refusal record(s) in our database, spanning from 8/24/2016 to 3/8/2024.
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's FEI number is 3012451201.
What types of violations has GELCAPS EXPORTADORA DE MEXICO received?
GELCAPS EXPORTADORA DE MEXICO 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 GELCAPS EXPORTADORA DE MEXICO come from?
All FDA import refusal data for GELCAPS EXPORTADORA DE MEXICO 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.