MEDICAL SUPPLIES CORPORATE, S DE R.L DE C.V.
⚠️ Moderate Risk
FEI: 3020763234 • Guadalupe, Nuevo Leon • MEXICO
FEI Number
3020763234
Location
Guadalupe, Nuevo Leon
Country
MEXICOAddress
Calle Primera Avenida, , Guadalupe, Nuevo Leon, 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
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
Frequently Asked Questions
What is MEDICAL SUPPLIES CORPORATE, S DE R.L DE C.V.'s FDA import refusal history?
MEDICAL SUPPLIES CORPORATE, S DE R.L DE C.V. (FEI: 3020763234) has 1 FDA import refusal record(s) in our database, spanning from 12/13/2024 to 12/13/2024.
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. MEDICAL SUPPLIES CORPORATE, S DE R.L DE C.V.'s FEI number is 3020763234.
What types of violations has MEDICAL SUPPLIES CORPORATE, S DE R.L DE C.V. received?
MEDICAL SUPPLIES CORPORATE, S DE R.L 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 MEDICAL SUPPLIES CORPORATE, S DE R.L DE C.V. come from?
All FDA import refusal data for MEDICAL SUPPLIES CORPORATE, S DE R.L 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.