Purple Surgical
⚠️ Moderate Risk
FEI: 3008439467 • Radlett, Hertfordshire • UNITED KINGDOM
FEI Number
3008439467
Location
Radlett, Hertfordshire
Country
UNITED KINGDOMAddress
Unit 2, Chestnut House; Farm Close, Radlett, Hertfordshire, 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
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/18/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | Division of Southeast Imports (DSEI) | |
| 8/18/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | Division of Southeast Imports (DSEI) | |
| 8/18/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | Division of Southeast Imports (DSEI) | |
| 8/18/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | Division of Southeast Imports (DSEI) | |
| 8/18/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | Division of Southeast Imports (DSEI) | |
| 8/18/2011 | 79GBXCATHETER, IRRIGATION | Division of Southeast Imports (DSEI) | |
| 8/18/2011 | 85LKFCANNULA, MANIPULATOR/INJECTOR, UTERINE | Division of Southeast Imports (DSEI) | |
| 8/18/2011 | 85LKFCANNULA, MANIPULATOR/INJECTOR, UTERINE | Division of Southeast Imports (DSEI) | |
| 8/18/2011 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | Division of Southeast Imports (DSEI) | |
| 8/18/2011 | 79JOSELECTRODE, ELECTROSURGICAL | Division of Southeast Imports (DSEI) | |
| 8/18/2011 | 85NKCTUBING/TUBING WITH FILTER, INSUFFLATION, LAPAROSCOPIC | Division of Southeast Imports (DSEI) | |
| 8/18/2011 | 79JOSELECTRODE, ELECTROSURGICAL | Division of Southeast Imports (DSEI) | |
| 8/18/2011 | 78NWUKIT, INTRODUCER, ENDOSCOPE | Division of Southeast Imports (DSEI) | |
| 8/18/2011 | 79GDIDISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY | Division of Southeast Imports (DSEI) | |
| 8/18/2011 | 74DRCTROCAR | Division of Southeast Imports (DSEI) | |
| 8/18/2011 | 74DRCTROCAR | Division of Southeast Imports (DSEI) | |
| 8/18/2011 | 74DRCTROCAR | Division of Southeast Imports (DSEI) | |
| 8/18/2011 | 74DRCTROCAR | Division of Southeast Imports (DSEI) | |
| 8/18/2011 | 74DRCTROCAR | Division of Southeast Imports (DSEI) | |
| 8/18/2011 | 79GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE | Division of Southeast Imports (DSEI) | |
| 9/2/2010 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | Florida District Office (FLA-DO) | |
| 9/2/2010 | 79GCYAPPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED | Florida District Office (FLA-DO) | |
| 9/2/2010 | 85LKFCANNULA, MANIPULATOR/INJECTOR, UTERINE | Florida District Office (FLA-DO) | |
| 9/2/2010 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | Florida District Office (FLA-DO) | |
| 9/2/2010 | 79JOSELECTRODE, ELECTROSURGICAL | Florida District Office (FLA-DO) | |
| 9/2/2010 | 78OCZENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED | Florida District Office (FLA-DO) | |
| 9/2/2010 | 79GDIDISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY | Florida District Office (FLA-DO) | |
| 9/2/2010 | 78FBQTROCAR, GASTRO-UROLOGY | Florida District Office (FLA-DO) | |
| 9/2/2010 | 79GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Purple Surgical's FDA import refusal history?
Purple Surgical (FEI: 3008439467) has 29 FDA import refusal record(s) in our database, spanning from 9/2/2010 to 8/18/2011.
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. Purple Surgical's FEI number is 3008439467.
What types of violations has Purple Surgical received?
Purple Surgical has been cited for 3 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 Purple Surgical come from?
All FDA import refusal data for Purple Surgical 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.