INTERNATIONAL WATERS PTY. LTD.
⚠️ Moderate Risk
FEI: 3010165498 • Helensvale, Queensland • AUSTRALIA
FEI Number
3010165498
Location
Helensvale, Queensland
Country
AUSTRALIAAddress
27 Millennium Circuit, , Helensvale, Queensland, 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
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).
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
Refusal History
Frequently Asked Questions
What is INTERNATIONAL WATERS PTY. LTD.'s FDA import refusal history?
INTERNATIONAL WATERS PTY. LTD. (FEI: 3010165498) has 2 FDA import refusal record(s) in our database, spanning from 10/24/2012 to 10/24/2012.
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. INTERNATIONAL WATERS PTY. LTD.'s FEI number is 3010165498.
What types of violations has INTERNATIONAL WATERS PTY. LTD. received?
INTERNATIONAL WATERS PTY. LTD. has been cited for 2 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 INTERNATIONAL WATERS PTY. LTD. come from?
All FDA import refusal data for INTERNATIONAL WATERS PTY. LTD. 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.