Sea Dragon De Maxico S De R.L. De
✅ Low Risk
FEI: 3009444107 • Campeche • MEXICO
FEI Number
3009444107
Location
Campeche
Country
MEXICOAddress
Calle 34 No 163, Col Centre, Campeche, , 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).
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.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
Refusal History
Frequently Asked Questions
What is Sea Dragon De Maxico S De R.L. De's FDA import refusal history?
Sea Dragon De Maxico S De R.L. De (FEI: 3009444107) has 1 FDA import refusal record(s) in our database, spanning from 4/13/2012 to 4/13/2012.
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. Sea Dragon De Maxico S De R.L. De's FEI number is 3009444107.
What types of violations has Sea Dragon De Maxico S De R.L. De received?
Sea Dragon De Maxico S De R.L. De 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 Sea Dragon De Maxico S De R.L. De come from?
All FDA import refusal data for Sea Dragon De Maxico S De R.L. De 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.