ELLA DEMCHUK C/O AMAZON.COM FBA
⚠️ Moderate Risk
FEI: 3022517561 • Seattle, WA • UNITED STATES
FEI Number
3022517561
Location
Seattle, WA
Country
UNITED STATESAddress
410 Terry Ave N, , Seattle, WA, United States
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
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
Frequently Asked Questions
What is ELLA DEMCHUK C/O AMAZON.COM FBA's FDA import refusal history?
ELLA DEMCHUK C/O AMAZON.COM FBA (FEI: 3022517561) has 1 FDA import refusal record(s) in our database, spanning from 1/15/2026 to 1/15/2026.
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. ELLA DEMCHUK C/O AMAZON.COM FBA's FEI number is 3022517561.
What types of violations has ELLA DEMCHUK C/O AMAZON.COM FBA received?
ELLA DEMCHUK C/O AMAZON.COM FBA 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 ELLA DEMCHUK C/O AMAZON.COM FBA come from?
All FDA import refusal data for ELLA DEMCHUK C/O AMAZON.COM FBA 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.