Edelweiss Phamaceiticals Cc
⚠️ Moderate Risk
FEI: 3007426904 • Retreat, Western Cape • SOUTH AFRICA
FEI Number
3007426904
Location
Retreat, Western Cape
Country
SOUTH AFRICAAddress
Po Box 307, , Retreat, Western Cape, South Africa
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
UNSAFE SUB
The article appears to bear or contain a substance which is unsafe within the meaning of Section 406.
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
Refusal History
Frequently Asked Questions
What is Edelweiss Phamaceiticals Cc's FDA import refusal history?
Edelweiss Phamaceiticals Cc (FEI: 3007426904) has 1 FDA import refusal record(s) in our database, spanning from 5/7/2009 to 5/7/2009.
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. Edelweiss Phamaceiticals Cc's FEI number is 3007426904.
What types of violations has Edelweiss Phamaceiticals Cc received?
Edelweiss Phamaceiticals Cc 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 Edelweiss Phamaceiticals Cc come from?
All FDA import refusal data for Edelweiss Phamaceiticals Cc 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.