Kestrel Opthalmics
⚠️ Moderate Risk
FEI: 3003983652 • Poole, Dorset • UNITED KINGDOM
FEI Number
3003983652
Location
Poole, Dorset
Country
UNITED KINGDOMAddress
463 Ashley Road, , Poole, 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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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
Frequently Asked Questions
What is Kestrel Opthalmics's FDA import refusal history?
Kestrel Opthalmics (FEI: 3003983652) has 2 FDA import refusal record(s) in our database, spanning from 4/28/2003 to 4/13/2004.
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 Opthalmics's FEI number is 3003983652.
What types of violations has Kestrel Opthalmics received?
Kestrel Opthalmics 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 Kestrel Opthalmics come from?
All FDA import refusal data for Kestrel Opthalmics 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.