SIGMA INK S DE RL DE CV
✅ Low Risk
FEI: 3015203383 • Tijuana, Baja California • MEXICO
FEI Number
3015203383
Location
Tijuana, Baja California
Country
MEXICOAddress
Prolongacion M. Juarez 1089-4b, Col. Lindavista, Tijuana, Tijuana, Baja California, 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).
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).
708LISTING
It has been determined the drug is not included in a list required by Section 510(j).
708NOREG
It has been determined the drug was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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 SIGMA INK S DE RL DE CV's FDA import refusal history?
SIGMA INK S DE RL DE CV (FEI: 3015203383) has 2 FDA import refusal record(s) in our database, spanning from 5/4/2020 to 1/4/2021.
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. SIGMA INK S DE RL DE CV's FEI number is 3015203383.
What types of violations has SIGMA INK S DE RL DE CV received?
SIGMA INK S DE RL DE CV has been cited for 5 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 SIGMA INK S DE RL DE CV come from?
All FDA import refusal data for SIGMA INK S DE RL DE CV 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.