Wrafton Laboratories
⚠️ Moderate Risk
FEI: 3004364143 • North Devon • UNITED KINGDOM
FEI Number
3004364143
Location
North Devon
Country
UNITED KINGDOMAddress
Wrafton Braunton, , North Devon, , United Kingdom
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).
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
Refusal History
Frequently Asked Questions
What is Wrafton Laboratories's FDA import refusal history?
Wrafton Laboratories (FEI: 3004364143) has 3 FDA import refusal record(s) in our database, spanning from 1/30/2006 to 5/10/2024.
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. Wrafton Laboratories's FEI number is 3004364143.
What types of violations has Wrafton Laboratories received?
Wrafton Laboratories 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 Wrafton Laboratories come from?
All FDA import refusal data for Wrafton Laboratories 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.