Ose Luis Aguascalientes
✅ Low Risk
FEI: 3009530087 • San Miguel De Allende, Guanajuato • MEXICO
FEI Number
3009530087
Location
San Miguel De Allende, Guanajuato
Country
MEXICOAddress
Callejon De Los Muertos No 25, Col. Barrio San Juan De Dios, San Miguel De Allende, San Miguel De Allende, Guanajuato, Mexico
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
Frequently Asked Questions
What is Ose Luis Aguascalientes's FDA import refusal history?
Ose Luis Aguascalientes (FEI: 3009530087) has 1 FDA import refusal record(s) in our database, spanning from 10/12/2012 to 10/12/2012.
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. Ose Luis Aguascalientes's FEI number is 3009530087.
What types of violations has Ose Luis Aguascalientes received?
Ose Luis Aguascalientes 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 Ose Luis Aguascalientes come from?
All FDA import refusal data for Ose Luis Aguascalientes 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.