Hilditch Group
⚠️ Moderate Risk
FEI: 3008707923 • Malmesbury, Wiltshire • UNITED KINGDOM
FEI Number
3008707923
Location
Malmesbury, Wiltshire
Country
UNITED KINGDOMAddress
Gloucester Road Industrial Estate, , Malmesbury, Wiltshire, 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.
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
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 |
|---|---|---|---|
| 11/21/2024 | 78LNKLASER FOR GASTRO-UROLOGY USE | Division of Northeast Imports (DNEI) | |
| 4/2/2024 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Division of West Coast Imports (DWCI) | |
| 4/2/2024 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Division of West Coast Imports (DWCI) | |
| 4/2/2024 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Hilditch Group's FDA import refusal history?
Hilditch Group (FEI: 3008707923) has 4 FDA import refusal record(s) in our database, spanning from 4/2/2024 to 11/21/2024.
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. Hilditch Group's FEI number is 3008707923.
What types of violations has Hilditch Group received?
Hilditch Group has been cited for 4 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 Hilditch Group come from?
All FDA import refusal data for Hilditch Group 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.