HSIN TEN ENTERPRISES MEXICO
✅ Low Risk
FEI: 3006555903 • Monterrey, Nuevo Leon • MEXICO
FEI Number
3006555903
Location
Monterrey, Nuevo Leon
Country
MEXICOAddress
Calle Licenciado Jose Benitez 2704, Col. Obispado, Monterrey, Monterrey, Nuevo Leon, 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
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
Frequently Asked Questions
What is HSIN TEN ENTERPRISES MEXICO's FDA import refusal history?
HSIN TEN ENTERPRISES MEXICO (FEI: 3006555903) has 1 FDA import refusal record(s) in our database, spanning from 5/15/2013 to 5/15/2013.
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. HSIN TEN ENTERPRISES MEXICO's FEI number is 3006555903.
What types of violations has HSIN TEN ENTERPRISES MEXICO received?
HSIN TEN ENTERPRISES MEXICO 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 HSIN TEN ENTERPRISES MEXICO come from?
All FDA import refusal data for HSIN TEN ENTERPRISES 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.