Idis Ltd
⚠️ Moderate Risk
FEI: 3002874409 • Surditon • UNITED KINGDOM
FEI Number
3002874409
Location
Surditon
Country
UNITED KINGDOMAddress
Millbank House171185 Ewell Road, , Surditon, , 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).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/19/2008 | 66VCH99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 3/23/2005 | 66VDP99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 7/30/2004 | 56YDB99ANTIBIOTIC N.E.C. | New York District Office (NYK-DO) | |
| 4/28/2004 | 56YAA99ANTIBIOTIC N.E.C. | New York District Office (NYK-DO) | |
| 7/2/2003 | 66VAA99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 3/11/2003 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 11/22/2002 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Idis Ltd's FDA import refusal history?
Idis Ltd (FEI: 3002874409) has 7 FDA import refusal record(s) in our database, spanning from 11/22/2002 to 3/19/2008.
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. Idis Ltd's FEI number is 3002874409.
What types of violations has Idis Ltd received?
Idis Ltd 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 Idis Ltd come from?
All FDA import refusal data for Idis 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.