Ultraceuticals C Ysl
⚠️ Moderate Risk
FEI: 3004555077 • Rydalmere, New South Wales • AUSTRALIA
FEI Number
3004555077
Location
Rydalmere, New South Wales
Country
AUSTRALIAAddress
Unit 4b1, 13 South St, Rydalmere, New South Wales, Australia
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
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).
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).
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 Ultraceuticals C Ysl's FDA import refusal history?
Ultraceuticals C Ysl (FEI: 3004555077) has 2 FDA import refusal record(s) in our database, spanning from 9/7/2004 to 12/16/2004.
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. Ultraceuticals C Ysl's FEI number is 3004555077.
What types of violations has Ultraceuticals C Ysl received?
Ultraceuticals C Ysl 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 Ultraceuticals C Ysl come from?
All FDA import refusal data for Ultraceuticals C Ysl 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.