Futura Medical Developments Limited
⚠️ Moderate Risk
FEI: 3024653717 • Guildford, Surrey • UNITED KINGDOM
FEI Number
3024653717
Location
Guildford, Surrey
Country
UNITED KINGDOMAddress
Unit 40, Surrey Technology Centre; Occam Road, Guildford, Surrey, 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.
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).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/30/2024 | 78QWWNON-MEDICATED TOPICAL FORMULATION FOR TREATMENT OF ERECTILE DYSFUNCTION. | Division of Southeast Imports (DSEI) | |
| 10/23/2024 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/23/2024 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/9/2022 | 85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Futura Medical Developments Limited's FDA import refusal history?
Futura Medical Developments Limited (FEI: 3024653717) has 4 FDA import refusal record(s) in our database, spanning from 12/9/2022 to 12/30/2024.
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. Futura Medical Developments Limited's FEI number is 3024653717.
What types of violations has Futura Medical Developments Limited received?
Futura Medical Developments Limited 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 Futura Medical Developments Limited come from?
All FDA import refusal data for Futura Medical Developments Limited 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.