Delta Laboratories Pty Ltd
✅ Low Risk
FEI: 3004085558 • Somersby, New South Wales • AUSTRALIA
FEI Number
3004085558
Location
Somersby, New South Wales
Country
AUSTRALIAAddress
8 Warringah Cl, , Somersby, New South Wales, Australia
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
Refusal History
Frequently Asked Questions
What is Delta Laboratories Pty Ltd's FDA import refusal history?
Delta Laboratories Pty Ltd (FEI: 3004085558) has 1 FDA import refusal record(s) in our database, spanning from 6/12/2013 to 6/12/2013.
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. Delta Laboratories Pty Ltd's FEI number is 3004085558.
What types of violations has Delta Laboratories Pty Ltd received?
Delta Laboratories 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 Delta Laboratories Pty Ltd come from?
All FDA import refusal data for Delta Laboratories 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.