Pumphouse Gb Ltd
⚠️ Moderate Risk
FEI: 3006144278 • West Yorkshire • UNITED KINGDOM
FEI Number
3006144278
Location
West Yorkshire
Country
UNITED KINGDOMAddress
Old Farm House Kirklees Park, , West Yorkshire, , 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).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/12/2008 | 60QAY07LIDOCAINE | 179AGR RX | New Orleans District Office (NOL-DO) |
| 2/12/2008 | 79JCYCATHETER, INFUSION | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 2/12/2008 | 65RCN12POTASSIC SALINE (INJECTION) (REPLENISHER) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 2/12/2008 | 65RCN12POTASSIC SALINE (INJECTION) (REPLENISHER) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 2/12/2008 | 79FGYCANNULA, INJECTION | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Pumphouse Gb Ltd's FDA import refusal history?
Pumphouse Gb Ltd (FEI: 3006144278) has 5 FDA import refusal record(s) in our database, spanning from 2/12/2008 to 2/12/2008.
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. Pumphouse Gb Ltd's FEI number is 3006144278.
What types of violations has Pumphouse Gb Ltd received?
Pumphouse Gb 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 Pumphouse Gb Ltd come from?
All FDA import refusal data for Pumphouse Gb 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.