Sigma Pharmaceuticals Pty Ltd
⚠️ Moderate Risk
FEI: 3007327554 • Croydon • AUSTRALIA
FEI Number
3007327554
Location
Croydon
Country
AUSTRALIAAddress
96 Merrindale Drive, , Croydon, , 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).
Refusal History
Frequently Asked Questions
What is Sigma Pharmaceuticals Pty Ltd's FDA import refusal history?
Sigma Pharmaceuticals Pty Ltd (FEI: 3007327554) has 2 FDA import refusal record(s) in our database, spanning from 11/16/2011 to 11/30/2012.
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. Sigma Pharmaceuticals Pty Ltd's FEI number is 3007327554.
What types of violations has Sigma Pharmaceuticals Pty Ltd received?
Sigma Pharmaceuticals 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 Sigma Pharmaceuticals Pty Ltd come from?
All FDA import refusal data for Sigma Pharmaceuticals 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.