Kestrel Medical
⚠️ Moderate Risk
FEI: 3008534738 • Broadstone, Dorset • UNITED KINGDOM
FEI Number
3008534738
Location
Broadstone, Dorset
Country
UNITED KINGDOMAddress
7 Moor Road, , Broadstone, Dorset, 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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/28/2023 | 62MAY08MENTHOL (ANTI-PRURITIC) | Division of Southeast Imports (DSEI) | |
| 12/19/2022 | 62MBY08MENTHOL (ANTI-PRURITIC) | Division of Southeast Imports (DSEI) | |
| 12/12/2022 | 62MAY08MENTHOL (ANTI-PRURITIC) | Division of Southeast Imports (DSEI) | |
| 8/23/2011 | 61LCB14CHLORHEXIDINE GLUCONATE | 483DRUG NAME | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Kestrel Medical's FDA import refusal history?
Kestrel Medical (FEI: 3008534738) has 4 FDA import refusal record(s) in our database, spanning from 8/23/2011 to 9/28/2023.
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. Kestrel Medical's FEI number is 3008534738.
What types of violations has Kestrel Medical received?
Kestrel Medical has been cited for 5 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 Kestrel Medical come from?
All FDA import refusal data for Kestrel Medical 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.