Hecho en Mexico Por: Representaciones E. Investigaciones
⚠️ Moderate Risk
FEI: 3006891337 • Zapopan • MEXICO
FEI Number
3006891337
Location
Zapopan
Country
MEXICOAddress
Carretera A Nogales No. 850, Laventa Del Astillero, Zapopan, , 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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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 Hecho en Mexico Por: Representaciones E. Investigaciones's FDA import refusal history?
Hecho en Mexico Por: Representaciones E. Investigaciones (FEI: 3006891337) has 1 FDA import refusal record(s) in our database, spanning from 5/22/2008 to 5/22/2008.
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. Hecho en Mexico Por: Representaciones E. Investigaciones's FEI number is 3006891337.
What types of violations has Hecho en Mexico Por: Representaciones E. Investigaciones received?
Hecho en Mexico Por: Representaciones E. Investigaciones has been cited for 4 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 Hecho en Mexico Por: Representaciones E. Investigaciones come from?
All FDA import refusal data for Hecho en Mexico Por: Representaciones E. Investigaciones 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.