Maquiladora Gana, S.A. de C.V.
⚠️ Moderate Risk
FEI: 3004263576 • San Luis Potosi, San Luis Potosi • MEXICO
FEI Number
3004263576
Location
San Luis Potosi, San Luis Potosi
Country
MEXICOAddress
General L. Martinez 500, Santiago Del Rio, San Luis Potosi, San Luis Potosi, 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
IMITN DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be an imitation of another drug. The artice resembles:
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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
Frequently Asked Questions
What is Maquiladora Gana, S.A. de C.V.'s FDA import refusal history?
Maquiladora Gana, S.A. de C.V. (FEI: 3004263576) has 2 FDA import refusal record(s) in our database, spanning from 10/8/2009 to 7/22/2011.
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. Maquiladora Gana, S.A. de C.V.'s FEI number is 3004263576.
What types of violations has Maquiladora Gana, S.A. de C.V. received?
Maquiladora Gana, S.A. de C.V. has been cited for 3 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 Maquiladora Gana, S.A. de C.V. come from?
All FDA import refusal data for Maquiladora Gana, 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.