Gran'S Remedies Ltd
⚠️ Moderate Risk
FEI: 3003236027 • Dunedin • NEW ZEALAND
FEI Number
3003236027
Location
Dunedin
Country
NEW ZEALANDAddress
South Dunedin, PO Box 2276, Dunedin, , New Zealand
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).
DR QUALITC
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
Refusal History
Frequently Asked Questions
What is Gran'S Remedies Ltd's FDA import refusal history?
Gran'S Remedies Ltd (FEI: 3003236027) has 1 FDA import refusal record(s) in our database, spanning from 5/4/2005 to 5/4/2005.
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. Gran'S Remedies Ltd's FEI number is 3003236027.
What types of violations has Gran'S Remedies Ltd received?
Gran'S Remedies 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 Gran'S Remedies Ltd come from?
All FDA import refusal data for Gran'S Remedies 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.