Magnotek Manufacturing De Mexico S.A. De C.V.
✅ Low Risk
FEI: 3002956406 • B.C.Mex • MEXICO
FEI Number
3002956406
Location
B.C.Mex
Country
MEXICOAddress
Paseo Morelos 800, , Tecate,B.C.Mex, , 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)
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 Magnotek Manufacturing De Mexico S.A. De C.V.'s FDA import refusal history?
Magnotek Manufacturing De Mexico S.A. De C.V. (FEI: 3002956406) has 2 FDA import refusal record(s) in our database, spanning from 9/16/2009 to 9/16/2009.
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. Magnotek Manufacturing De Mexico S.A. De C.V.'s FEI number is 3002956406.
What types of violations has Magnotek Manufacturing De Mexico S.A. De C.V. received?
Magnotek Manufacturing De Mexico 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 Magnotek Manufacturing De Mexico S.A. De C.V. come from?
All FDA import refusal data for Magnotek Manufacturing De Mexico 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.